A Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This will be a single centre, Phase 1, First-In-Human, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Dose of APB-R3 in Healthy Participants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:
• Male or female, non-smoker, 18 to 60 years of age (both inclusive),
• Healthy as defined by:
‣ the absence of clinically significant illness and surgery within 4 weeks prior to study drug administration in the opinion of the investigator.
⁃ the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease in the opinion of the investigator.
Locations
Other Locations
Australia
CMAX Clinical Research
Adelaide
Time Frame
Start Date: 2023-03-08
Completion Date: 2023-12-19
Participants
Target number of participants: 31
Treatments
Experimental: SAD cohort
SAD cohorts 1-5. Randomised participants in each cohort will receive a single IV dose of APB-R3.
Placebo_comparator: Placebo
SAD cohorts 1-5. 2 randomised participants of each cohort will receive a placebo.
Related Therapeutic Areas
Sponsors
Collaborators: AprilBio Co., Ltd.
Leads: Syneos Health