Status:
COMPLETED
SAD Study of APR002 Investigating the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics in Healthy Subjects
Lead Sponsor:
Global Health Drug Discovery Institute
Collaborating Sponsors:
CMAX Clinical Research Pty Limited
Avance Clinical Pty Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of APR002 in healthy subjects.
Detailed Description
A Phase 1, Randomized, Blinded, Placebo-Controlled, First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APR002 Administered by I...
Eligibility Criteria
Inclusion
- Healthy men or women aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing to continue on the chosen contraceptive method
- Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months
- Have a body mass index (BMI) between 18 and 32 kg/m2 and weigh at least 45 kg.
Exclusion
- History or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, COVID-19, etc.) or psychiatric condition or disease
- Abnormal vital signs, after minutes rest, defined as any of the following (SBP \> 140 mmHg, Diastolic blood pressure (DBP) \> 90 mmHg, Heart rate \< 40 or \> 99 beats per minute)
- Prolonged QTcF \> 450 ms or family history of long QT syndrome
Key Trial Info
Start Date :
March 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05268198
Start Date
March 20 2023
End Date
July 27 2023
Last Update
August 2 2023
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000