NCT06412185 · Phase 1 · RECRUITING
Single Dose Escalation Study of CM383 in Healthy Volunteers
This trial is testing CM383, a biological drug candidate, in healthy male volunteers for the first time in humans. Researchers want to know if it is safe, how the body processes it, and whether it triggers any immune response. This is a Phase 1 trial, meaning the main goal is basic safety testing — it is not yet known whether the drug works or is approved for anything.
You may qualify if
- Healthy males, voluntarily participate;
- 18 and 80 years old (including boundary values);
- able to communicate well with the researchers and follow up the protocol requirements.
You're excluded if
- The average daily smoking volume within three months before screening is greater than 5 cigarettes;
- Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
- Urine drug abuse screening is positive;
- Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-11-08