First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05275855
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 7.6

Study Details

Study Description

Brief Summary

A first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of EDI048 administered orally in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: EDI048; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A First-in-human, Randomized, Participant and Investigator Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers
• Anticipated Study Start Date: Mar 22, 2022
• Anticipated Primary Completion Date: Nov 8, 2022
• Anticipated Study Completion Date: Nov 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: EDI048 or Placebo Part A is a single ascending dose study	Drug: EDI048; Oral Liquid; Other: Placebo; Oral Liquid
Experimental: Part B: EDI048 or Placebo Part B is a multiple ascending dose study	Drug: EDI048; Oral Liquid; Other: Placebo; Oral Liquid

Outcome Measures

Primary Outcome Measures

1. Number of participants with Adverse Events (AEs) [From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 8.5 weeks for Part A and 9 weeks for Part B]

   Number of participants with AEs and Serious Adverse Events (AEs), including significant changes from baseline in vital signs, electrocardiograms and laboratory assessments qualifying and reported as AEs.

Secondary Outcome Measures

1. Parts A and B: Cmax [up to 13 days]

   Characterize the Cmax profile following EDI048 dosing

2. Parts A and B: Tmax [up to 13 days]

   Characterize the Tmax profile following EDI048 dosing

3. Parts A and B: AUClast [up to 13 days]

   Characterize the AUClast profile following EDI048 dosing

4. Parts A and B: AUCinf [up to 13 days]

   Characterize the AUCinf profile following EDI048 dosing

5. Parts A and B: T1/2 [up to 13 days]

   Characterize the T1/2 profile following EDI048 dosing

6. Part B: AUC0-12h [up to 13 days]

   Characterize the AUC0-12h profile following EDI048 dosing

7. Part B: Accumulation (Racc) [up to 13 days]

   Characterize the Racc profile following EDI048 dosing

8. Part A: Renal Clearance (CLr) [up to 13 days]

   Characterize the CLr profile following EDI048 dosing

9. Part A: Ae0-t [up to 3 day]

   Assess amount of EDI048 excreted in urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.

• Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2. BMI = Body weight (kg) / [Height (m)]2

• At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the participant has rested for at least three (3) minutes, and again in the standing position. Supine vital signs should be within the following ranges:

• oral body temperature between 35.0-37.5 °C

• systolic blood pressure, 90-139 mmHg

• diastolic blood pressure, 50-89 mmHg

• pulse rate, 40-90 bpm

Exclusion Criteria:

• Participants who have received any IMP in a clinical research study within 90 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.

• History of multiple and recurring allergies or allergy or hypersensitivity to any of the study treatments, excipients or drugs of similar chemical classes. Hay fever is allowed unless it is active at time of screening or if there is a risk that it may become active during the study.

• Pregnant or nursing (lactating) women, assessed at screening and baseline.

• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.

• Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 7 days after stopping the investigational drug.

Additional protocol-defined inclusion / exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05275855
• Other Study ID Numbers: CEDI048A02101
• First Posted: Mar 11, 2022
• Last Update Posted: Mar 11, 2022
• Last Verified: Mar 1, 2022

• 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

Study Results

No Results Posted as of Mar 11, 2022