A Study of the Safety, Tolerability, Pharmacokinetics and Food Effect After Single and Multiple Ascending Oral Doses
- Conditions
- Autoimmune Diseases
- Registration Number
- NCT05218434
- Lead Sponsor
- Artax Biopharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 64
Inclusion Criteria:<br><br> 1. Healthy Male participant, between 18 and 50 years of age, inclusive.<br><br> 2. Male participant (and partner of childbearing potential) willing to use a highly<br> effective method of contraception in addition to a condom, if applicable (unless<br> anatomically sterile or where abstaining from sexual intercourse is in line with the<br> preferred and usual lifestyle of the participant) from first dose until 4 months<br> after last dose of Investigational Medicinal Product (IMP).<br><br> 3. Participant with a body mass index (BMI) of 18-30kg/m2. BMI = body weight (kg) /<br> [height (m)]2.<br><br> 4. Total serum bilirubin, alkaline phosphatase (ALP), aspartate transaminase (AST) and<br> alanine transaminase (ALT) = 1.5 x upper limit of normal (ULN). If total bilirubin<br> is above the upper limit of normal and is then fractionated, direct bilirubin must<br> be within normal limits.<br><br> 5. Total serum Testosterone levels 2 x above the lower limit of the normal range within<br> 28 days before the first dose administration of the IMP.<br><br> 6. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol)<br> test results, determined within 28 days before the first dose administration of the<br> IMP (N.B.: A positive test result may be repeated at the Investigator's discretion).<br><br> 7. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface<br> antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening.<br><br> 8. No clinically significant abnormalities in 12-lead electrocardiogram (ECG)<br> determined within 28 days before first dose of IMP including a QRS interval > 120ms,<br> PR interval > 220ms and QTcF > 450ms.<br><br> 9. No clinically significant abnormalities in vital signs (e.g., blood pressure/pulse<br> rate, respiration rate and oral temperature) determined within 28 days before first<br> dose of IMP.<br><br> 10. Participant must be available to complete the study (including all follow-up<br> visits).<br><br> 11. Participant must satisfy an Investigator about his fitness to participate in the<br> study.<br><br> 12. Participant must provide written informed consent to participate in the study.<br><br> 13. Participants with a negative COVID-19 PCR test on admission.<br><br>Exclusion Criteria:<br><br> 1. A clinically significant history of gastrointestinal disorder likely to influence<br> IMP absorption.<br><br> 2. Use of prescription or non-prescription drugs, including vitamins, herbal and<br> dietary supplements within 28 days or 5 half-lives (whichever is longer) prior to<br> the first dose of IMP. Occasional use of paracetamol will be allowed.<br><br> 3. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular, or<br> metabolic dysfunction.<br><br> 4. Clinically significant history of previous allergy / sensitivity to AX-158 or any of<br> the excipients contained within the IMP.<br><br> 5. Participant with history of autoimmune disease, cardiac disease, kidney disease or<br> any food intolerance.<br><br> 6. Participants with clinically significant abnormal test results for serum<br> biochemistry, haematology and/or urine analyses within 28 days before the first dose<br> administration of the IMP<br><br> 7. A clinically significant history of drug or alcohol abuse (defined as the<br> consumption of more than 14 units [for male and female participants] of alcohol a<br> week) within the past two years.<br><br> 8. Inability to communicate well with the Investigators (i.e., language problem, poor<br> mental development, or impaired cerebral function).<br><br> 9. Participation in a New Chemical Entity (NCE) clinical study within the previous 3<br> months or five half-lives, whichever is longer, or a marketed drug clinical study<br> within the 30 days or five half-lives, whichever is longer, before the first dose of<br> IMP. (Washout period between studies is defined as the period of time elapsed<br> between the last dose of the previous study and the first dose of the next study).<br><br> 10. Donation of 450 milliliters or more blood within the 3 months before the first dose<br> of IMP.<br><br> 11. Vegans, vegetarians, or other dietary restrictions (e.g., restrictions for medical,<br> religious, or cultural reasons, etc), which would prevent participants from<br> consuming a high-fat breakfast or standardised meal.<br><br> 12. Users of nicotine products i.e., current smokers or ex-smokers who have smoked<br> within the 6 months prior to screening or users of cigarette replacements (i.e.,<br> e-cigarettes, nicotine patches or gums).<br><br> 13. Participants who have received a COVID-19 vaccine injection within 28 days prior to<br> the first dose of IMP.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events
- Secondary Outcome Measures
Name Time Method Maximal Plasma Concentration (Cmax);Total Plasma Drug Exposure (AUC0-t);Terminal Half Life (t1/2)