Single-dose Alpha-0261 in healthy adults
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
This test gives single oral doses of the experimental tablet Alpha-0261 to healthy adults to see how safe it is and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | AlphaMol Science Ltd. (Shanghai) Industry-sponsored |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT07279636 on ClinicalTrials.gov |
What this trial studies
This Phase 1, interventional trial administers single oral doses of Alpha-0261 or placebo to healthy adult volunteers and monitors them for safety and tolerability. Blood samples are collected over time to measure pharmacokinetics and pharmacodynamic markers. Participants undergo regular laboratory tests, vital sign checks, and ECGs as required to detect any adverse effects. Findings will inform dosing and safety for later-stage studies.
Who should consider this trial
Good fit: Healthy men and women aged 18–55 with BMI between 19 and 28 and meeting the study's weight and lab criteria are ideal candidates.
Not a fit: People with significant medical conditions, abnormal clinical labs, a history of severe allergic reactions, or who fall outside the age/weight/BMI limits are unlikely to qualify or receive benefit.
Why it matters
Potential benefit: If successful, the trial could show Alpha-0261 is safe and predictable in the body, supporting further development for therapeutic use.
How similar studies have performed: Single-dose Phase 1 trials commonly define safety and pharmacokinetics for new drugs, but there are no widely available prior results specific to Alpha-0261.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chongqing
- Bishan Hospital of Chongqing — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Lei Wan
- Email: roxray@163.com
- Phone: +86 15320494896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.