A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088

• Sponsor: InFlectis BioScience (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03610334
• Collaborator: Qualissima (Other), Assistance Publique Hopitaux De Marseille (Other), Stragen France (Industry), Eurofins Optimed (Industry)
• Enrollment: 72
• Locations: 2
• Arms: 18
• Actual Duration (Months): 17.8
• Patients Per Site: 36
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses of IFB-088 in healthy subjects (Single Ascending Doses - SAD) and in a second part safety, tolerability, plasma and urine pharmacokinetics (PK) of multiple oral doses of IFB-088 in healthy subjects (Multiple Ascending Doses - MAD)

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: IFB-088 (2.5-60.0mg) oral capsule; Drug: Placebo (2.5-60.mg) oral capsule; Drug: IFB-088 (15.0-50.0mg) oral capsule; Drug: Placebo oral (15.0-50.0mg) capsule	Phase 1

Detailed Description

Randomized, double blind, placebo controlled study of single ascending doses (SAD) and multiple ascending doses (MAD).

The SAD part consists of 6 cohorts of 8 healthy young male subjects, each receiving a single oral dose of IFB-088 or placebo (6 verum and 2 placebo). In each cohort, 2 subjects (1 verum and 1 placebo) will be dosed first. If the safety and tolerability results are acceptable, the 6 remaining subjects will be dosed by 2 successive groups of 3 subjects, with an adequate period between the 2 groups to detect the occurrence of any reaction or adverse events, namely at least 48H for the first cohort and at least 36H for the following cohorts. Indeed, in the first cohort (2.5 mg IFB-088 base), dosing will be in the morning only. From the second cohort, the planned daily dose will be divided into 2 doses separated by an interval of 12 hours (1 dose in the morning fasting and 1 dose in the evening 2 hours before dinner).

The MAD part consists of 3 cohorts of 8 healthy young male subjects, each receiving an oral dose divided into two doses of IFB-088 or placebo (6 verum and 2 placebo) for 14 days. In each cohort, the 2 first subjects will be dosed on Day 1 (one on active treatment and one on placebo). The 6 remaining subjects will be dosed by 2 successive groups of maximum 3 subjects with an adequate period between the groups to observe for any reaction and adverse events. This period will be of at least 36H, corresponding to at least 5-fold the half-life of the drug (based on results obtained during the SAD part) when steady state will be achieved. In each MAD cohort, the total daily dose will be divided into 2 doses separated by an interval of 12 hours.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts studydouble-blind, randomized, placebo-controlled, combined single and multiple ascending dose of IFB-088 by successive cohorts study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Capsules used for verum or placebo (Size 5 white opaque HPMC capsule) are identical and equally-weighted
• Primary Purpose: Other
• Official Title: A Double-blind, Randomized, Placebo-controlled, Combined Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088, in Healthy Volunteers
• Actual Study Start Date: Jun 21, 2018
• Actual Primary Completion Date: Jun 21, 2019
• Actual Study Completion Date: Dec 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAD IFB-088 2.5mg Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake	Drug: IFB-088 (2.5-60.0mg) oral capsule; SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: verum
Placebo Comparator: SAD Placebo 2.5mg Cohort 1: A single daily dose of 2.5mg placebo in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake	Drug: Placebo (2.5-60.mg) oral capsule; SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: placebo
Experimental: SAD IFB-088 5.0mg Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: IFB-088 (2.5-60.0mg) oral capsule; SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: verum
Placebo Comparator: SAD Placebo 5.0mg Cohort 2: A single daily dose of 5.0mg placebo in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: Placebo (2.5-60.mg) oral capsule; SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: placebo
Experimental: SAD IFB-088 10.0mg Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: IFB-088 (2.5-60.0mg) oral capsule; SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: verum
Placebo Comparator: SAD Placebo 10.0mg Cohort 3: A single daily dose of 10.0mg Placebo in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: Placebo (2.5-60.mg) oral capsule; SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: placebo
Experimental: SAD IFB-088 20.0mg Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: IFB-088 (2.5-60.0mg) oral capsule; SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: verum
Placebo Comparator: SAD Placebo 20.0mg Cohort 4: A single daily dose of 20.0mg Placebo in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: Placebo (2.5-60.mg) oral capsule; SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: placebo
Experimental: SAD IFB-088 40.0mg Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: IFB-088 (2.5-60.0mg) oral capsule; SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: verum
Placebo Comparator: SAD Placebo 40.0mg Cohort 5: A single daily dose of 40.0mg Placebo in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: Placebo (2.5-60.mg) oral capsule; SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: placebo
Experimental: SAD IFB-088 60.0mg Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: IFB-088 (2.5-60.0mg) oral capsule; SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: verum
Experimental: SAD Placebo 60.0mg Cohort 6: A single daily dose of 60.0mg Placebo in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm	Drug: Placebo (2.5-60.mg) oral capsule; SAD phase: placebo (microcrystalline cellulosis) will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours; Other Names: placebo
Experimental: MAD IFB-088 15 mg Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.	Drug: IFB-088 (15.0-50.0mg) oral capsule; MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.; Other Names: verum
Placebo Comparator: MAD Placebo 15 mg Cohort 7: subject taking 15.0mg of placebo in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.	Drug: Placebo oral (15.0-50.0mg) capsule; MAD phase: multiple doses of placebo (microcrystalline cellulosis, 15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.; Other Names: placebo
Experimental: MAD IFB-088 30 mg Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.	Drug: IFB-088 (15.0-50.0mg) oral capsule; MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.; Other Names: verum
Placebo Comparator: MAD Placebo 30 mg Cohort 8: subject taking 30.0mg of Placebo in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.	Drug: Placebo oral (15.0-50.0mg) capsule; MAD phase: multiple doses of placebo (microcrystalline cellulosis, 15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.; Other Names: placebo
Experimental: MAD IFB-088 50 mg Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.	Drug: IFB-088 (15.0-50.0mg) oral capsule; MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.; Other Names: verum
Placebo Comparator: MAD Placebo 50 mg Cohort 9: subject taking 50.0mg of Placebo in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days.	Drug: Placebo oral (15.0-50.0mg) capsule; MAD phase: multiple doses of placebo (microcrystalline cellulosis, 15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.; Other Names: placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events Per Group [SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days]

   This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment. As all the parameters are developped in the pharmacovigilance section, please do refer to that section for further details.

Secondary Outcome Measures

1. Number of Participants With Change in Concomitant Medications [SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days)]

   modification in Concomitant medication(s) occuring during the study (if applicable)

2. Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax) [Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)]

   Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).

3. Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax) [Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)]

   Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).

4. Pharmacokinetic: Terminal Half-life (t1/2) [Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)]

   Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).

5. Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast) [Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)]

   Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).

6. Pharmacokinetic: Apparent Volume of Distribution (Vd/F) [Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)]

   Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).

7. Pharmacokinetic: Apparent Total Body Clearance (CL/F) [Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)]

   Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32h SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32h MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).

8. Pharmacokinetic: Renal Clearance (CLr) [Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)]

   Urine samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0-4 hours, 4-8 hours, 8-16 hours,16-32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14

9. Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose) [Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)]

   Urine samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0-4 hours, 4-8 hours, 8-16 hours,16-32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14

10. Number of Participants With Clinically Significant Change in Physical Evaluation During the Study [SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)]

    the following parameters are assessed during the physical evaluation visit: Cardiovascular system (see specific outcome measure), Digestive system (included spleen organ), alcohol consumption (Ethylotest), General condition, Liver and biliary tracts, Lymphatic system, Muco-cutaneous system, Neck/Thyroide, Nervous system, ENTsystem, Respiratory system, Visual system

11. Number of Participants With Clinically Significant Change in Physiological Parameters During the Study [SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)]

    Weight measured in kg and height measured in cm, were taken and Body Mass Index was calculated using those 2 values

12. Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study [From screening visit until end of study visit (7 to 14 days after last dosing)]

    This safety outcome aims at monitoring cardiovascular functions and identify potential adverse events/reactions (clinical assessment combined with ECGs and vital signs assessments).

13. Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study [SAD phase (cohorts 1 to 6):Screening, Day -1;Day 1 ;end (7 to 14 days after last dosing) MAD phase: Screening;Day -1; Day 1 ;predose at Day 2, Day 4, Day 6, Day 8, Day 10, Day 12; Day 14 ; Day 17; end (7 to 14 days after last dosing)]

    Tympanic body temperature will be measured at the time frame described underneath.at the following Timepoints : change in body temperature (fever) will be reported per patient per group.

14. Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study [SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose, at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)]

    This safety outcome aims at monitoring hematology parameters: Red blood cell (RBC) count, hemoglobin, hematocrit, white blood cell (WBC) count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelets, reticulocyte count will be monitored from screening to end of study visit (7 to 14 days after last dosing), at several time points. When a participant experienced clinically significant change in the parameter, at least once during the study, he/she is recorded in the table.

15. Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study [SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day ; Day 17; end of study visit (7 to 14 days after last dosing)]

    This safety outcome aims at monitoring coagulation parameters such as Activated partial thromboplastin time (APTT), international normalized ratio (INR)

16. Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study [SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)]

    This safety outcome aims at monitoring the following blood biochemistry parameters: Sodium, potassium, chloride, calcium, total bilirubin, alanine aminotransferase (ASAT), aspartate aminotransferase (ALAT), gamma-glutamyl transferase (GGT), alkaline phosphatases, total protein, albumin, urea, uric acid, bicarbonate, creatine phosphokinase (CPK), creatinine, glycaemia, lactate dehydrogenase (LDH), total cholesterol, HDL and LDL cholesterol, triglycerides

17. Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study [SAD phase: Screening; Day -1; Day 1 (predose, 12, 24, 32 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 1, Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)]

    This safety outcome aims at monitoring urinary functions/parameters: Specific gravity, pH, glucose, protein, blood, nitrites, leucocytes and ketones by dipstick. Results are given as "absent" or "present, not clinically significant" or "present clinically significant". A cytobacteriological exam will be done if abnormal results on dipstick). Beta 2 microglobulin (B2M), proteinuria and creatinuria will be also monitored.

18. Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study [SAD Phase: Screening; Day 1 (predose, 1.5, 12, 32 hours) MAD Phase: Screening; Day 1 (predose, 1.5, 12 hours); Day 14 (predose, 1.5, 12 hours)]

    Assessment and monitoring of the vigilance/mood of healthy volunteers through the use of a Bond-Lader Visual Analogue Scale listing 16 mood items, with 2 words at the beginning and the end of the scale bar. Depending on the item, the scale would go from better to worse (ie strong to weak) or the opposite (Hostile to friendly). Alertness, Self-contentment, Calmness are computed by averaging their respective items and are mentionned in the volunteer file.

Other Outcome Measures

1. SAD Exploratory Biomarkers Analysis [SAD phase: Day 1 at predose, 1.5 hours and 24 hours]

   Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified

2. MAD Exploratory Biomarkers Analysis [MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours]

   Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy male 18 to 40 years of age inclusive, Caucasian.

2. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG.

3. AST, ALT, alkaline phosphatase and bilirubin < or = 1.5xULN (isolated bilirubin

1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

1. ECG (12 leads) normal (120<PR<200ms; QRS<120ms; QTcF<450ms) and/or without clinically relevant impairments as judged by investigator.

2. Non-smoker, or user of not more than tobacco- or nicotine-containing products ≤ 5 cigarettes a day.

3. Negative screen for alcohol and drugs of abuse at screening and admission.

4. No history of psychiatric disorders assessed by a clinical psychological evaluation and the Mini International Neuropsychiatric Interview (MINI).

5. Body mass index (BMI) between 19 and 27 kg/m² inclusive.

6. Subject with female partners of child bearing potential must agree to use one of the contraception methods listed in Section 6.6.1 (Contraception requirements). This criterion must be followed from the time of the first dose of study medication until the follow up visit (for female partners) and with an additional period of 90 days (for subjects themselves).

7. Willing and able to understand and sign an approved Informed Consent Form.

8. Able to understand the protocol and to come to the visits.

9. Who is, in the judgement of the investigator likely to be compliant during the study.

10. Subject registered in the VRB file (volontaires se prêtant à des recherches impliquant la personne humaine).

11. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria:

1. 1. History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.

2. History of relevant atopy or drug hypersensitivity.

3. Known allergy to any component of IFB-088 oral capsule or its placebo (HPMC or cellulose microcrystalline).

4. History of major medical, psychiatric illness or surgery which, in the judgment of the investigator, puts them 'at risk' or is likely to modify their handling of the study drug.

5. Acute or chronic systemic disease or disorder (respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine).

6. Impaired renal function defined by a creatinine clearance < 90 mL/min calculated using the Cockcroft-Gault equation (according the FDA Guidance for Industry: Pharmacokinetics in patients with Impaired Renal Function, March 2010).

7. History of nephritic colic and/or renal calculi.

8. History of drug abuse and/or regular use of tobacco- or nicotine-containing products > 5/day within three months of the study.

9. History of alcohol consumption exceeding, (on average 21 drinks/week for men) within 6 months of the first dose of study medication.

10. Drinking excessive amounts of tea, coffee, chocolate and/or beverage containing caffeine (> 4 cups / day).

11. Vital signs with a clinically significant abnormality at screening.

12. ECG with a clinically significant abnormality at screening.

13. Laboratory test values outside the clinically acceptable 'normal range' for healthy volunteers at screening.

14. Positive HIV, Hepatitis B or Hepatitis C at screening.

15. Positive urine drug test or positive breath alcohol test at screening or at admission to the clinical unit.

16. Any medication (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever is the longest (except paracetamol).

17. Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to screening.

18. Unable to refrain from consumption of grapefruit or grapefruit juice within 7 days prior to the first dose of study medication.

19. Unwillingness to abstain from sexual intercourse with pregnant or lactating women or to use a condom and spermicide and another form of contraception (e.g., IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant until discharge from the study and during 90 additional days.

20. Subjects unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.

21. Subject being in the exclusion period of a previous trial.

22. Subject having exceeded the earnings for the last 12 months, including the indemnities for the present study.

23. Subject who could not be contacted in case of emergency.

24. Subject refusing to give written informed consent.

25. Subject who has received blood or plasma derivatives in the year preceding the study.

26. Subject who has given blood within the past 3 months or has planned to give blood or sperm within the 90 days following the study.

27. Subject who has forfeited their freedom by administrative or legal award, or who is under guardianship or under limited judicial protection.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurofins|Optimed	Gières		France	38610
2	Centre d'Investigation Clinique - Centre de Pharmacologie Clinique et d'Evaluations Thérapeutiques (CIC-CPCET)	Marseille		France	13385

Sponsors and Collaborators

• InFlectis BioScience
• Qualissima
• Assistance Publique Hopitaux De Marseille
• Stragen France
• Eurofins Optimed

Investigators

• Principal Investigator: Christine Audebert, MD, APHM - Centre de Pharmacolgie Clinique et d'Evaluations Thérapeutiques

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 6, 2019

More Information

Additional Information:

• Website of InFlectis BioScience

Publications

None provided.

• Responsible Party: InFlectis BioScience
• ClinicalTrials.gov Identifier: NCT03610334
• Other Study ID Numbers: P188; 2018-000443-29
• First Posted: Aug 1, 2018
• Last Update Posted: Jan 26, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by InFlectis BioScience: First-In-Human

Study Results

Participant Flow

Arm/Group Title	SAD IFB-088 2.5 mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	A single daily dose of IFB-088 2.5 mg is administered to 6 healthy volunteers	A single daily dose of placebo (microcristalline cellusose) 2.5 mg is administered to 2 healthy volunteers	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 5.0 mg is administered to 6 healthy volunteers, in two intakes of 2.5mg, separated by 12h.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellulose) 5.0 mg is administered to 2 healthy volunteers, in two intakes of 2.5mg, separated by 12h.	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 10.0 mg is administered to 6 healthy volunteers, in two intakes of 5.0mg, separated by 12h.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 10.0 mg is administered to 2 healthy volunteers, in two intakes of 5.0mg, separated by 12h.	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 20.0 mg is administered to 6 healthy volunteers, in two intakes of 10.0mg, separated by 12h.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 20.0 mg is administered to 2 healthy volunteers, in two intakes of 10.0mg, separated by 12h.	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 40.0 mg is administered to 6 healthy volunteers, in two intakes of 20.mg, separated by 12h.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 40.0 mg is administered to 2 healthy volunteers, in two intakes of 20.0mg, separated by 12h.	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of IFB-088 60.0 mg is administered to 6 healthy volunteers, in two intakes of 30.0mg, separated by 12h.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A single daily dose of placebo (microcrystalline cellusose) 60.0 mg is administered to 2 healthy volunteers, in two intakes of 30.0mg, separated by 12h.	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study. A single dose of IFB-088 15.0 mg is administered to 6 healthy volunteers, during 14 days	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the Single Ascending Dose Study. A single dose of placebo (microcrystalline cellulose) 15.0 mg is administered to 2 healthy volunteers, during 14 days	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of IFB-088 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of placebo (microcrystalline cellulose) 30.0 mg is administered in two intakes of 15.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days.	Administration of the drug to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of IFB-088 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 6 healthy volunteers, during 14 days.	Administration of the placebo to this group of new healthy volunteers is conditionned to the safety obtained in the previous period. A dose of placebo (microcrystalline cellulose) 50.0 mg is administered in two intakes of 25.0mg, administered at 12hours of interval, to 2 healthy volunteers, during 14 days.
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	6	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	6	2	6	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	0	0	0	0	0	0	0	0	0	0	0	0
COMPLETED	6	2	6	2	6	2	0	0	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	6	2	0	0	0	0	0	0	0	0	0	0
COMPLETED	6	2	6	2	6	2	6	2	0	0	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	6	2	6	2	0	0	0	0	0	0	0	0
COMPLETED	6	2	6	2	6	2	6	2	6	2	0	0	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	6	2	6	2	6	2	0	0	0	0	0	0
COMPLETED	6	2	6	2	6	2	6	2	6	2	6	2	0	0	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	6	2	6	2	6	2	6	2	0	0	0	0
COMPLETED	6	2	6	2	6	2	6	2	6	2	6	2	6	2	0	0	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	0	0
COMPLETED	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	0	0
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Period Title: Period 1: 2.5mg (1 Day)
STARTED	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
COMPLETED	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Cohort 1: SAD IFB-088 2.5mg	Cohort 2: SAD IFB-088 5.0mg	Cohort 3: SAD IFB-088 10.0mg	Cohort 4: SAD IFB-088 20.0mg	Cohort 5: SAD IFB-088 40.0mg	Cohort 6: SAD IFB-088 60.0mg	Cohort 7: MAD IFB-088 15.0mg	Cohort 8: MAD IFB-088 30.0mg	Cohort 9: MAD IFB-088 50.0mg	SAD Placebo Group	MAD Placebo Group	Total
Arm/Group Description	a single daily dose of 2.5mg IFB-088 in oral capsule, is administered in the morning (8:00am), in one intake	a single daily dose of 5.0mg IFB-088 in oral capsule, divided into 2 doses of 2.5mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)	a single daily dose of 10.0mg IFB-088 in oral capsule, divided into 2 doses of 5.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)	a single daily dose of 20.0mg IFB-088 in oral capsule, divided into 2 doses of 10.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)	a single daily dose of 40.0mg IFB-088 in oral capsule, divided into 2 doses of 20.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)	a single daily dose of 60.0mg IFB-088 in oral capsule, divided into 2 doses of 30.0mg, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)	subject taking 15.0mg of IFB-088 in oral capsule, divided into 2 doses of 7.5mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days	subject taking 30.0mg of IFB-088 in oral capsule, divided into 2 doses of 15.0mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days	subject taking 50.0mg of IFB-088 in oral capsule, divided into 2 doses of 25.0mg, separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days	a single daily dose of placebo in oral capsule, divided into 1 or 2 doses equivalent to verum, is administered, separated by an interval of 12h (in the morning (8:00am), and in the evening (8:00pm)	subject taking placebo equivalent to the verum dose in oral capsule, divided into 2 doses , separated by an interval of 12 hours, in the morning (8:00am), and in the evening (8:00pm), for 14 days	Total of all reporting groups
Overall Participants	6	6	6	6	6	6	6	6	6	12	6	72
Age (Year) [Mean (Full Range) ]
subject age	31.0	25.5	27.5	24.7	24.5	25.5	27.0	31.7	31.0	26.5	31.7	26.5
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	12 100%	6 100%	72 100%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	12 100%	6 100%	72 100%
Region of Enrollment (participants) [Number]
France	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	12 100%	6 100%	72 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events Per Group
Description	This safety outcome lists the number of subjects experiencing adverse events (AEs), whether not related, possibly or unlikely related to the study treatment. As all the parameters are developped in the pharmacovigilance section, please do refer to that section for further details.
Time Frame	SAD & MAD phases: Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days

Outcome Measure Data

Analysis Population Description

72 Healthy volunteers included in the study, from inclusion visit, up to study disclosure visit, were followed for TEAE. As this this study was a first in human dose escalating study, if TEAE occured in a group, they were analysed by an independant safety commity as not related, unlikely related or possibly related to the study drug, to evaluate safety of the drug and allow to raise the dose in the next group.

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg once daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg once daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
Count of Participants [Participants]	1 16.7%	0 0%	1 16.7%	1 16.7%	2 33.3%	0 0%	2 33.3%	0 0%	2 33.3%	1 8.3%	3 50%	0 0%	4 NaN	1 NaN	1 NaN	0 NaN	4 NaN	1 NaN

2. Secondary Outcome

Title	Number of Participants With Change in Concomitant Medications
Description	modification in Concomitant medication(s) occuring during the study (if applicable)
Time Frame	SAD & MAD phases: Continuous (Screening visit to End of study visit (7 to 14 days after last dosing) + 30 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
add-on: acetaminophen 1000mg 1/day	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	1 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
add-on: naproxen 550mg bid	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
add-on: fexofenadine 180mg 1/day	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
add-on: desloratadine 5 mg as needed	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants without change	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	5 83.3%	2 33.3%	5 83.3%	2 16.7%	4 66.7%	2 2.8%	5 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

3. Secondary Outcome

Title	Pharmacokinetic: Maximum Observed Plasma Concentration (Cmax)
Description	Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Outcome Measure Data

Analysis Population Description

6 patients per cohort have received the verum and are presented. In all groups but one, patients received the verum twice daily. Cmax has hence been measured twice. In the SAD IFB-088 2.5mg cohort, 0 patient received dose 2 as only 1 dose (dose 1) of 2.5mg was given to the patient therefore Cmax Dose 2 has not been measured.

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15.0mg	MAD IFB-088 30.0mg	MAD IFB-088 50.0mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	6	6	6	6	6	6	6	6	6
Cmax Dose 1	0.54 (34.5)	0.45 (62.3)	1.19 (75.5)	1.39 (16.3)	2.93 (35.2)	4.26 (46.3)	1.70 (87.1)	2.52 (54.0)	4.38 (49.8)
Cmax Dose 2	0.37 (59.7)	1.13 (44.2)	1.52 (34.3)	2.39 (31.2)	4.52 (50.6)	1.61 (47.2)	3.58 (41.1)	6.92 (52.3)

4. Secondary Outcome

Title	Pharmacokinetic: Time to Reach the Maximum Concentration in Plasma (Tmax)
Description	Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Outcome Measure Data

Analysis Population Description

6 patients per cohort have received the verum and are presented. In all groups but one, patients received the verum twice daily. Tmax has hence been measured twice. In the SAD IFB-088 2.5mg cohort, 0 patient received dose 2 as only 1 dose (dose 1) of 2.5mg was given to the patient therefore Tmax Dose 2 has not been measured.

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	6	6	6	6	6	6	6	6	6
Tmax Dose 1	1.5	1.5	2.0	2.0	1.0	2.0	2.0	2.0	2.0
Tmax Dose 2	2.0	2.0	2.0	1.0	2.0	2.0	2.0	2.0

5. Secondary Outcome

Title	Pharmacokinetic: Terminal Half-life (t1/2)
Description	Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	6	6	6	6	6	6	6	6	6
Mean (Standard Deviation) [h]	4.64 (33.3)	4.61 (56.5)	5.92 (33.8)	6.21 (26.9)	5.76 (10.8)	5.17 (11.8)	6.97 (33.1)	5.70 (22.9)	6.34 (28.7)

6. Secondary Outcome

Title	Pharmacokinetic: Area Under Plasma Concentration-time Curve From Hour 0 to Last Sample With Measurable Plasma Concentrations (AUClast)
Description	Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	6	6	6	6	6	6	6	6	6
Mean (Standard Deviation) [ng*h/mL]	2.25 (50.6)	3.80 (95.2)	12.5 (47.9)	17.4 (41.7)	27.4 (32.5)	51.1 (40.0)	18.7 (49.5)	40.8 (35.7)	77.2 (48.8)

7. Secondary Outcome

Title	Pharmacokinetic: Apparent Volume of Distribution (Vd/F)
Description	Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Outcome Measure Data

Analysis Population Description

6 patients per cohort have received the verum and are presented. In all groups but one (SAD IFB-088 2.5mg), patients received the verum twice daily. Data were not collected for the SAD IFB-088 2.5 and 5.0mg cohorts

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	0	0	6	6	6	6	6	6	6
Mean (Standard Deviation) [L]	5093 (16.9)	10055 (33.2)	10408 (16.4)	10550 (65.5)	8916 (41.1)	6860 (43.0)	7042 (54.5)

8. Secondary Outcome

Title	Pharmacokinetic: Apparent Total Body Clearance (CL/F)
Description	Plasma samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 24, 32h SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0.33, 0.66, 1, 2, 3, 4, 5, 12, 12.25, 12.5, 13, 14, 16, 18, 24, 32h MAD phase (two intakes for daily administration): Day 1 and Day 14 at predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 17, 19 and 21h ; Day 2 (24 hours); Day 7 (predose, 1h and 2 h post dose); Day 15 (24, 30, 36 and 42 hours after Day 14); Day 16 (48, 60 hours after Day 14).
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 72 hours after last dosing (Day 17)

Outcome Measure Data

Analysis Population Description

6 patients per cohort have received the verum and are presented. In all groups but one (SAD IFB-088 2.5mg), patients received the verum twice daily. Data were not collected for the SAD IFB-088 2.5 and 5.0mg cohorts

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	0	0	6	6	6	6	6	6	6
Mean (Standard Deviation) [L/h]	736 (43.0)	1146 (45.1)	1279 (13.9)	1388 (61.6)	926 (34.7)	826 (38.3)	843 (28.0)

9. Secondary Outcome

Title	Pharmacokinetic: Renal Clearance (CLr)
Description	Urine samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0-4 hours, 4-8 hours, 8-16 hours,16-32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)

Outcome Measure Data

Analysis Population Description

Data were not collected for the SAD IFB-088 2.5 mg cohort

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	0	6	6	6	6	6	6	6	6
Mean (Standard Deviation) [mL/min]	167 (55.8)	75.3 (44.6)	117 (22.3)	106 (32.4)	60.5 (37.6)	76.6 (34.0)	84.4 (45.0)	66.2 (36.4)

10. Secondary Outcome

Title	Pharmacokinetic: Percent of Drug Recovered in Urine (Ae %Dose)
Description	Urine samples are collected: SAD phase - cohort 1 (one intake for daily administration): Day 1 at predose, 0-4 hours, 4-8 hours, 8-16 hours,16-32 hours SAD phase - cohort 2 to 6 (two intakes for daily administration): Day 1 at predose, 0-4, 4-8, 8-12, 12-24, 24-32 hours MAD phase (two intakes for daily administration): Day 1 and Day 14: predose, 0-4, 4-12, 12-24 hours; Day 6: predose, 0-4 and 4-12 hours; Day 15: 24-36, 36-48 hours after Day 14
Time Frame	Starting 1 hour prior to dosing on Day 1 and until 48 hours after last dosing (Day 16)

Outcome Measure Data

Analysis Population Description

6 patients per cohort have received the verum and are presented. In all groups but one (SAD IFB-088 2.5mg), patients received the verum twice daily. Data were not collected for the SAD IFB-088 2.5 cohort

Arm/Group Title	SAD IFB-088 2.5mg	SAD IFB-088 5.0mg	SAD IFB-088 10.0mg	SAD IFB-088 20.0mg	SAD IFB-088 40.0mg	SAD IFB-088 60.0mg	MAD IFB-088 15 mg	MAD IFB-088 30 mg	MAD IFB-088 50 mg
Arm/Group Description	Cohort 1: A single daily dose of 2.5mg IFB-088 in oral capsule, is administered with 250 ml of water at room temperature, in the morning around 8:00am, in one intake IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 2: A single daily dose of 5.0mg IFB-088 in oral capsule, divided in two doses of 2.5mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 3: A single daily dose of 10.0mg IFB-088 in oral capsule, divided in two doses of 5.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 4: A single daily dose of 20.0mg IFB-088 in oral capsule, divided in two doses of 10.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 5: A single daily dose of 40.0mg IFB-088 in oral capsule, divided in two doses of 20.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 6: A single daily dose of 60.0mg IFB-088 in oral capsule, divided in two doses of 30.0mg are administered with 250 ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, and in the evening around 8:00pm IFB-088 (2.5-60.0mg) oral capsule: SAD phase: IFB-088 will be administered during 1 day, in one (2.5mg) or 2 (5.0-60.0mg) intakes separated by an interval of 12 hours	Cohort 7: subject taking 15.0mg of IFB-088 in oral capsule divided into 2 doses of 7.5mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 8: subject taking 30.0mg of IFB-088 in oral capsule divided into 2 doses of 15.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.	Cohort 9: subject taking 50.0mg of IFB-088 in oral capsule divided into 2 doses of 25.0mg administered with 250ml of water at room temperature, seperated by an interval of 12h, in the morning around 8:00am, an in the evening around 8:00pm, for 14 days. IFB-088 (15.0-50.0mg) oral capsule: MAD phase: multiple doses of IFB-088 (15.0-50.0mg) will be administered daily during 14 days, in two intakes, separated by an interval of 12 hours.
Measure Participants	0	6	6	6	6	6	6	6	6
Mean (Standard Deviation) [mg/day]	0.52 (67.7)	0.55 (49.6)	0.61 (46.2)	0.44 (44.9)	0.29 (39.7)	0.61 (52.5)	0.74 (56.8)	0.63 (39.7)

11. Secondary Outcome

Title	Number of Participants With Clinically Significant Change in Physical Evaluation During the Study
Description	the following parameters are assessed during the physical evaluation visit: Cardiovascular system (see specific outcome measure), Digestive system (included spleen organ), alcohol consumption (Ethylotest), General condition, Liver and biliary tracts, Lymphatic system, Muco-cutaneous system, Neck/Thyroide, Nervous system, ENTsystem, Respiratory system, Visual system
Time Frame	SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
cardiavascular system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
digestive system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
general condition	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
liver and biliary tract	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
lymphatic system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
muco-cutaneous system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
ENT system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
respiratory system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
visual system	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with no clinically significant changes	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	5 83.3%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

12. Secondary Outcome

Title	Number of Participants With Clinically Significant Change in Physiological Parameters During the Study
Description	Weight measured in kg and height measured in cm, were taken and Body Mass Index was calculated using those 2 values
Time Frame	SAD & MAD phases: Screening; Day 2 (SAD) or Day 17 (MAD); and at End of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
Number of subjects with clinically significant change in weight	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant change in BMI	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants without clinically significant changes	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

13. Secondary Outcome

Title	Number of Participants With With Clinically Significant Change in Cardiovascular Functions During the Study
Description	This safety outcome aims at monitoring cardiovascular functions and identify potential adverse events/reactions (clinical assessment combined with ECGs and vital signs assessments).
Time Frame	From screening visit until end of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
Number of participants with clinically significant change in electrocardiogram parameters (ECG)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with no clinically significant changes in ECG	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

14. Secondary Outcome

Title	Number of Participants With With Clinically Significant Change in Tympanic Body Temperature During the Study
Description	Tympanic body temperature will be measured at the time frame described underneath.at the following Timepoints : change in body temperature (fever) will be reported per patient per group.
Time Frame	SAD phase (cohorts 1 to 6):Screening, Day -1;Day 1 ;end (7 to 14 days after last dosing) MAD phase: Screening;Day -1; Day 1 ;predose at Day 2, Day 4, Day 6, Day 8, Day 10, Day 12; Day 14 ; Day 17; end (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
Nr of participants presenting clinically significant change in tympanic body temp. during the study	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Nr of participants without clinically significant change in tympanic body temp. throughout the study	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

15. Secondary Outcome

Title	Number of Participants With With Clinically Significant Change in Hematology Parameters During the Study
Description	This safety outcome aims at monitoring hematology parameters: Red blood cell (RBC) count, hemoglobin, hematocrit, white blood cell (WBC) count (neutrophils, lymphocytes, monocytes, eosinophils, basophils), platelets, reticulocyte count will be monitored from screening to end of study visit (7 to 14 days after last dosing), at several time points. When a participant experienced clinically significant change in the parameter, at least once during the study, he/she is recorded in the table.
Time Frame	SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose, at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
Number of participants with clinically significant changes in eosinophils at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in haemoglobin at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in haematocrit at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in lymphocytes at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in monocytes at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in neutrophils at one timepoint	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in platelets at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in reb blood cells at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in reticulocytes at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in leucocytes at one timepoint	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Number of participants with clinically significant changes in white blood cells at one timepoint	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Nr of participants without clinically significant changes in hematology param. throughout the study	6 100%	2 33.3%	6 100%	2 33.3%	4 66.7%	2 33.3%	6 100%	2 33.3%	5 83.3%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

16. Secondary Outcome

Title	Number of Participants With With Clinically Significant Change in Coagulation Parameters During the Study
Description	This safety outcome aims at monitoring coagulation parameters such as Activated partial thromboplastin time (APTT), international normalized ratio (INR)
Time Frame	SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day ; Day 17; end of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
number of participants with clinically significant changes in INR during the study	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in APTT during the study	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants without clinically significant changes in coagulation throughout the study	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

17. Secondary Outcome

Title	Number of Participants With With Clinically Significant Change in Blood Biochemistry Parameters During the Study
Description	This safety outcome aims at monitoring the following blood biochemistry parameters: Sodium, potassium, chloride, calcium, total bilirubin, alanine aminotransferase (ASAT), aspartate aminotransferase (ALAT), gamma-glutamyl transferase (GGT), alkaline phosphatases, total protein, albumin, urea, uric acid, bicarbonate, creatine phosphokinase (CPK), creatinine, glycaemia, lactate dehydrogenase (LDH), total cholesterol, HDL and LDL cholesterol, triglycerides
Time Frame	SAD phase: Screening; Day -1; Day 2 (24 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
number of participants with clinically significant changes in ion (Na, K, Cl, Ca, HCO3)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in aminotransferases (ASAT, ALAT, GGT)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in cholesterol (total, HDL, LDL)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in triglycerides	0 0%	0 0%	1 16.7%	1 16.7%	1 16.7%	0 0%	0 0%	1 16.7%	0 0%	0 0%	2 33.3%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in glycaemia	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in total bilirubin	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in alkaline phosphatases	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in total protein	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in albumin	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in urea and uric acid	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Nr of participants with clinically significant changes in creatinine and creatinine phosphokinase	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes in lactate dehydrogenase (LDH)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
Nr of participants without clinically significant changes in biochem. param. throughout the study	6 100%	2 33.3%	5 83.3%	1 16.7%	5 83.3%	2 33.3%	6 100%	1 16.7%	6 100%	2 16.7%	4 66.7%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

18. Secondary Outcome

Title	Number of Participants With Clinically Significant Change in Urinary Functions/Parameters During the Study
Description	This safety outcome aims at monitoring urinary functions/parameters: Specific gravity, pH, glucose, protein, blood, nitrites, leucocytes and ketones by dipstick. Results are given as "absent" or "present, not clinically significant" or "present clinically significant". A cytobacteriological exam will be done if abnormal results on dipstick). Beta 2 microglobulin (B2M), proteinuria and creatinuria will be also monitored.
Time Frame	SAD phase: Screening; Day -1; Day 1 (predose, 12, 24, 32 hours); end of study visit (7 to 14 days after last dosing) MAD phase: Screening; Day -1; predose at Day 1, Day 3, Day 6, Day 10, Day 13; Day 17; end of study visit (7 to 14 days after last dosing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
Nr of participants with clinically significant change of parameters present on dispstick (see above)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes of beta2 microglobulin	0 0%	0 0%	0 0%	0 0%	00 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes of proteinuria	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants with clinically significant changes of creatinuria	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants without clinically significant changes of urinary parameters	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

19. Secondary Outcome

Title	Number of Participants With Clinically Significant Change in Vigilance and Mood During the Study
Description	Assessment and monitoring of the vigilance/mood of healthy volunteers through the use of a Bond-Lader Visual Analogue Scale listing 16 mood items, with 2 words at the beginning and the end of the scale bar. Depending on the item, the scale would go from better to worse (ie strong to weak) or the opposite (Hostile to friendly). Alertness, Self-contentment, Calmness are computed by averaging their respective items and are mentionned in the volunteer file.
Time Frame	SAD Phase: Screening; Day 1 (predose, 1.5, 12, 32 hours) MAD Phase: Screening; Day 1 (predose, 1.5, 12 hours); Day 14 (predose, 1.5, 12 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	SAD IFB-088 2.5mg	SAD Placebo 2.5mg	SAD IFB-088 5.0mg	SAD Placebo 5.0mg	SAD IFB-088 10.0mg	SAD Placebo 10.0mg	SAD IFB-088 20.0mg	SAD Placebo 20.0mg	SAD IFB-088 40.0mg	SAD Placebo 40.0mg	SAD IFB-088 60.0mg	SAD Placebo 60.0mg	MAD IFB-088 15.0mg	MAD Placebo 15.0mg	MAD IFB-088 30.0mg	MAD Placebo 30.0mg	MAD IFB-088 50.0mg	MAD Placebo 50.0mg
Arm/Group Description	healthy volunteers received IFB-088 2.5mg once daily, in the morning.	healthy volunteers received placebo 2.5mg once daily, in the morning.	healthy volunteers received IFB-088 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received placebo 5.0mg once daily, in two doses of 2.5mg, separated by a 12h interval.	healthy volunteers received IFB-088 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received placebo 10.0mg once daily, in two doses of 5.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received placebo 20.0mg once daily, in two doses of 10.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received placebo 40.0mg once daily, in two doses of 20.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received placebo 60.0mg once daily, in two doses of 30.0mg, separated by a 12h interval.	healthy volunteers received IFB-088 15.0mg daily, in the morning, during 14 days.	healthy volunteers received placebo 15.0mg daily, in the morning, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 30.0mg daily, in two doses of 15.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received IFB-088 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.	healthy volunteers received placebo 50.0mg daily, in two doses of 25.0mg, separated by a 12h. interval, during 14 days.
Measure Participants	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2	6	2
number of participants with clinically significant changes of vigilance or mood during the study	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN	0 NaN
number of participants without clinically significant changes of vigilance or mood during the study	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 33.3%	6 100%	2 16.7%	6 100%	2 2.8%	6 NaN	2 NaN	6 NaN	2 NaN	6 NaN	2 NaN

20. Other Pre-specified Outcome

Title	SAD Exploratory Biomarkers Analysis
Description	Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified
Time Frame	SAD phase: Day 1 at predose, 1.5 hours and 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Other Pre-specified Outcome

Title	MAD Exploratory Biomarkers Analysis
Description	Blood samples will be collected and stored in a biobank to explore potential biomarkers that remain to be identified
Time Frame	MAD phase: Day 1 and Day 14 at predose, 1.5 hours and 24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	18 months
Adverse Event Reporting Description	Safety was the primary endpoint of this Phase 1 study Number of participants with TEAE are reported in the primary endpoint section. As this section is more appropriate to describe TEAE, it was decided to further describe the primary endpoint in this section.
Arm/Group Title	SAD IFB-088 2.5mg		SAD IFB-088 5.0mg		SAD IFB-088 10.0mg		SAD IFB-088 20.0mg		SAD IFB-088 40.0mg		SAD IFB-088 60.0mg		SAD Placebo		MAD IFB-088 15.0mg		MAD IFB-088 30.0mg		MAD IFB-088 50.0mg		MAD Placebo
Arm/Group Description	cohort 1: single daily dose of 2.5mg IFB-088 oral capsule, administered in the morning (8:00am), in one intake		cohort 2: single daily dose of 5.0mg IFB-088 oral capsule, administered in two intakes of 2.5mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)		cohort 3: single daily dose of 10.0mg IFB-088 oral capsule, administered in two intakes of 5.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)		cohort 4: single daily dose of 20.0mg IFB-088 oral capsule, administered in two intakes of 10.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)		cohort 5: single daily dose of 40.0mg IFB-088 oral capsule, administered in two intakes of 20.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)		cohort 6: single daily dose of 60.0mg IFB-088 oral capsule, administered in two intakes of 30.0mg, 12 hours apart, in the morning (8:00am), and in the evening (8:00pm)		(cohort 1 to 6): single daily dose of placebo oral capsule, administered in two intakes (except for the first SAD dose that is administered in one intake), at 12h intervals, in the morning (8:00am) and in the evening (8:00pm)		cohort 7: subject taking 15.0mg of IFB-088 oral capsule divided in two dose of 7.5mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.		cohort 8: subject taking 30.0mg of IFB-088 oral capsule divided in two dose of 15.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.		cohort 9: subject taking 50.0mg of IFB-088 oral capsule divided in two dose of 25.0mg, at an interval of 12h, in the morning (8:00am), and in the evening (8:00pm), for 14 days.		(cohort 7 to 9): subject taking placebo oral capsule divided in two doses, at an interval of 12h, in the morning (8:00am), and in the evning (8:00pm), for 14 days.
All Cause Mortality
	SAD IFB-088 2.5mg		SAD IFB-088 5.0mg		SAD IFB-088 10.0mg		SAD IFB-088 20.0mg		SAD IFB-088 40.0mg		SAD IFB-088 60.0mg		SAD Placebo		MAD IFB-088 15.0mg		MAD IFB-088 30.0mg		MAD IFB-088 50.0mg		MAD Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Serious Adverse Events
	SAD IFB-088 2.5mg		SAD IFB-088 5.0mg		SAD IFB-088 10.0mg		SAD IFB-088 20.0mg		SAD IFB-088 40.0mg		SAD IFB-088 60.0mg		SAD Placebo		MAD IFB-088 15.0mg		MAD IFB-088 30.0mg		MAD IFB-088 50.0mg		MAD Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/12 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	SAD IFB-088 2.5mg		SAD IFB-088 5.0mg		SAD IFB-088 10.0mg		SAD IFB-088 20.0mg		SAD IFB-088 40.0mg		SAD IFB-088 60.0mg		SAD Placebo		MAD IFB-088 15.0mg		MAD IFB-088 30.0mg		MAD IFB-088 50.0mg		MAD Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/6 (16.7%)		1/6 (16.7%)		2/6 (33.3%)		2/6 (33.3%)		2/6 (33.3%)		3/6 (50%)		2/12 (16.7%)		4/6 (66.7%)		1/6 (16.7%)		4/6 (66.7%)		2/6 (33.3%)
Ear and labyrinth disorders
ear pain	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Gastrointestinal disorders
toothache	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
diarrhoea	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
nausea	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/6 (33.3%)	2	0/6 (0%)	0
abdominal pain	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
General disorders
pyrexia	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
catheter site related reaction	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
influenza like illness	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Infections and infestations
nasopharyngitis	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Injury, poisoning and procedural complications
joint injury	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Metabolism and nutrition disorders
hypertriglyceridemia	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	2/6 (33.3%)	2	2/12 (16.7%)	2	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Nervous system disorders
headache	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	2/6 (33.3%)	2	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
paraesthesia	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
presyncope	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Renal and urinary disorders
nephrolithiasis	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
haematuria	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
pollakyuria	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Respiratory, thoracic and mediastinal disorders
rhinitis allergic	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/12 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Vascular disorders
orthostatic hypotension	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/12 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results.