Study of CM383 in Healthy Subjects

Recruiting now · Phase 1

Conditions studied: Healthy

In brief

This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.

Key facts

Study ID

NCT07292688

Run by

Keymed Biosciences Co.Ltd

People needed

30

Starts

2026-01-01

Expected to finish

2026-07-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older, up to 54. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Subjects age ≥ 18 years \& ≤54 years.
• Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

You may not qualify if…

• The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
• Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
• History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
• Blood donation or any other form of blood loss exceeding 400 mL, or accepting blood transfusion within 12 weeks prior to screening.
• Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
• Severe trauma or undergo major surgery within 6 months prior to screening, or planned surgery during the research period.

Where it is running

• The Second Affiliated Hospital Zhejiang University School of Medcine — Hangzhou, China (enrolling)

Full record on ClinicalTrials.gov

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