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A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses

Sponsor
Artax Biopharma Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05218434
Collaborator
Simbec-Orion Group (Industry)
104
Enrollment
1
Location
3
Arms
7.6
Anticipated Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase I Healthy volunteer study with the primary objective to evaluate the safety and pharmacokinetics profile of AX-158. The first part will evaluate single ascending dose administrations. A substudy will be performed as well to evaluate possible impact of food on drug exposure if administered under fasted or fed state. The second part will evaluate multiple ascending dose over 10 days of dosing in fed or fast state depending on the results of the substudy food effect on AX-158.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a phase I, randomised, double-blind , placebo controlled study to investigate the safety, tolerability, and PK of AX-158 in healthy male participants following single (Part A) and multiple (Part C) ascending doses including food effect (Part B).The study will be conducted in three parts (Part A, Part B and Part C). Part A will enrol 8 participants per cohort randomised (3 :1) to receive AX-158 (6 participants) or placebo (2 participants). Part A will follow a single ascending dose (SAD) design with all participants receiving one dose of AX-158 (or placebo) in the fasted state. Part B (Food Effect) will be conducted in 8 participants in a cross-over manner; each participant will receive AX-158 in the fed and fasted state. Part C will enrol 8 participants per cohort randomised to (3 :1) to receive AX-158 (6 participants) or placebo (2 participants). Part C will follow a multiple ascending dose (MAD) design with participants receiving AX-158 (or placebo) once daily for 10 consecutive days, in a fed or fasted state (depending on the outcome of the Part B (Food Effect).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of AX-158 Following Administration of Single and, Multiple Ascending Oral Doses and Food Effect Sub-study in Healthy Male Volunteers
Actual Study Start Date :
Dec 14, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug (AX-158 or Placebo)

Rising single doses of AX-158 oral or placebo.

Drug: AX-158
Oral administrations of AX-158
Other Names:
  • Placebo

    		•
    Experimental: Drug (AX-158)

    Oral single dose with and without food

    Drug: AX-158
    Oral administrations of AX-158
    Other Names:
  • Placebo

    		•
    Experimental: Drug (AX-158 and Placebo)

    Rising multiple doses of AX-158 oral or placebo for 10 days.

    Drug: AX-158
    Oral administrations of AX-158
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events [Up to 10 days of treatment]

      The number and severity of adverse events that can be related to treatment with single and multiple doses of ARTAX

    Secondary Outcome Measures

    1. The pharmacokinetics (PK) of single and multiple dose administration of ARTAX in volunteers [Up to 10 days]

      Maximal plasma concentration (Cmax)

    2. Total Plasma Drug Exposure of a single and multiple dose administration of ARTAX in volunteers [Up to 10 days]

      Measurement of the area under the curve (AUC) at day 1 and day 10 in plasma

    3. Comparison of the single dose and multiple dose elimination of ARTAX [Up to 10 days]

      Determination of the half-life (T1/2) for single and multiple doses of ARTAX

    4. Total Plasma Drug Exposure of single dose administration of ARTAX under fasting and fed conditions in volunteers [Three days]

      Measurement of the area under the curve (AUC) after single dose administration of ARTAX after an overnight fast or after a high fat breakfast

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Healthy Male participant, between 18 and 50 years of age, inclusive.

    2. Male participant (and partner of childbearing potential) willing to use a highly effective method of contraception in addition to a condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 4 months after last dose of Investigational Medicinal Product (IMP).

    3. Participant with a body mass index (BMI) of 18-30kg/m2. BMI = body weight (kg) / [height (m)]2.

    4. Total serum bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN). If total bilirubin is above the upper limit of normal and is then fractionated, direct bilirubin must be within normal limits.

    5. Total serum Testosterone levels 2 x above the lower limit of the normal range within 28 days before the first dose administration of the IMP.

    6. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator's discretion).

    7. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.

    8. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP including a QRS interval > 120ms, PR interval

    220ms and QTcF > 450ms.

    1. No clinically significant abnormalities in vital signs (e.g., blood pressure/pulse rate, respiration rate and oral temperature) determined within 28 days before first dose of IMP.

    2. Participant must be available to complete the study (including all follow-up visits).

    3. Participant must satisfy an Investigator about his fitness to participate in the study.

    4. Participant must provide written informed consent to participate in the study.

    5. Participants with a negative COVID-19 PCR test on admission.

    Exclusion Criteria:

    1. A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.

    2. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP. Occasional use of paracetamol will be allowed.

    3. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction.

    4. Clinically significant history of previous allergy / sensitivity to AX-158 or any of the excipients contained within the IMP.

    5. Participant with history of autoimmune disease, cardiac disease, kidney disease or any food intolerance.

    6. Participants with clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP

    7. A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units [for male and female participants] of alcohol a week) within the past two years.

    8. Inability to communicate well with the Investigators (i.e., language problem, poor mental development, or impaired cerebral function).

    9. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).

    10. Donation of 450 milliliters or more blood within the 3 months before the first dose of IMP.

    11. Vegans, vegetarians, or other dietary restrictions (e.g., restrictions for medical, religious, or cultural reasons, etc), which would prevent participants from consuming a high-fat breakfast or standardised meal.

    12. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).

    13. Participants who have received a COVID-19 vaccine injection within 28 days prior to the first dose of IMP.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Simbec-Orion Merthyr Tydfil United Kingdom

    Sponsors and Collaborators

    • Artax Biopharma Inc
    • Simbec-Orion Group

    Investigators

    • Principal Investigator: Dr Annelize Koch, Simbec-Orion Merthyr Tydfil CF48 4DR, United Kingdom

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Artax Biopharma Inc
    ClinicalTrials.gov Identifier:
    NCT05218434
    Other Study ID Numbers:
    • AX-158-101
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    Feb 1, 2022
    Last Verified:
    Dec 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
    Additional relevant MeSH terms:
    Autoimmune Diseases

    Study Results

    No Results Posted as of Feb 1, 2022