Single-dose CM383 in healthy adult men

A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CM383 Following Intravenous and Subcutaneous Administration in Healthy Adult Subjects

This trial will test a single dose of CM383 given by IV infusion or subcutaneous injection in healthy adult men to see how the drug is processed, whether it triggers immune responses, and if it is safe.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 54 Years
• Sex: Male
• Sponsor: Keymed Biosciences Co.Ltd (industry)
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07292688 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-center, randomized, open-label, parallel-controlled study in healthy male volunteers. Participants aged 18–54 receive a single dose of CM383 either by intravenous infusion or by subcutaneous injection, with serial sampling to measure pharmacokinetics, pharmacodynamics, and immunogenicity. Safety and tolerability are monitored through adverse event reporting, vital signs, and laboratory testing during follow-up visits. Results will guide dose selection, preferred administration route, and safety monitoring for later clinical studies.

Who should consider this trial

Good fit: Healthy men aged 18–54 who can give informed consent, comply with study procedures, and have no recent heavy alcohol or tobacco use, drug abuse, major surgery, or allergies to similar biologics.

Not a fit: People with active medical conditions, women, heavy smokers or drinkers, recent drug users, or those with known allergies to monoclonal antibody drugs are unlikely to receive benefit from participating.

Why it matters

Potential benefit: If successful, the study could identify a safe dose and the best way to give CM383 to inform later-stage testing.

How similar studies have performed: Single-dose PK/PD and safety studies in healthy volunteers are routine for biologic therapies, and comparable monoclonal antibodies have often shown predictable pharmacokinetics and manageable safety in Phase I.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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 this trial is running

Hangzhou

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

Study contacts

• Principal investigator: Bo Jiang — The Second Affiliated Hospital Zhejiang University School of Medcine
• Study coordinator: Qian Jia

Conditions: Healthy