NCT07279636
Recruiting
Phase 1
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
AlphaMol Science Ltd. (Shanghai)1 site in 1 country60 target enrollmentJuly 21, 2025
Overview
- Phase
- Phase 1
- Intervention
- Alpha-0261
- Conditions
- Not specified
- Sponsor
- AlphaMol Science Ltd. (Shanghai)
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Frequency of treatment emergent adverse events
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Single Ascending Dose
Intervention: Alpha-0261
Single Ascending Dose (placebo)
Intervention: Placebo
Outcomes
Primary Outcomes
Frequency of treatment emergent adverse events
Time Frame: From enrollment to end of follow-up visit, up to approximately 1 week
Secondary Outcomes
- Plasma PK of Alpha-0261 after single dose(From enrollment to end of treatment period, up to approximately 7 days)
Study Sites (1)
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