RecruitingPhase 1NCT07279636
A Study to Evaluate Single Doses of Alpha-0261 in Healthy Adult Volunteers
A Randomized, Double-blind, Placebo-Controlled, Dose-Escalation, Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Administration of Alpha-0261 Tablets in Adult Healthy Participants
Sponsor
AlphaMol Science Ltd. (Shanghai)
Enrollment
60 participants
Start Date
Jul 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Alpha-0261 tablets after single oral administration in healthy adult volunteers.
Eligibility
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria3
- Aged ≥ 18 and ≤ 55, male or female
- Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2
- In general good health
Exclusion Criteria3
- Have a history of any severe allergic reaction or anaphylaxis
- Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol
- Have clinically significant abnormalities on clinical laboratory results
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Interventions
DRUGAlpha-0261
Oral, tablet
OTHERPlacebo
Oral, tablet
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07279636
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