A Study to Evaluate Single Doses of Alpha-0261 in Healthy Adult Volunteers
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.
| Condition(s) | Healthy Volunteers |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | AlphaMol Science Ltd. (Shanghai) |
| Locations | Chongqing, China |
| Start date | 2025-07-21 |
| NCT ID | NCT07279636 |
| Official listing | https://clinicaltrials.gov/study/NCT07279636 |