Single intravenous CM559 dosing in healthy adult men

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM559 in Healthy Subjects With Single Ascending Dose Administration

This trial tests single intravenous doses of CM559 to see if they are safe and how the drug is processed in healthy men aged 18–60.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: Male
• Sponsor: Keymed Biosciences Co.Ltd (Industry-sponsored)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07175506 on ClinicalTrials.gov

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase I trial in healthy male volunteers. Participants receive one intravenous dose of CM559 or placebo at ascending dose levels with close safety monitoring. The study measures safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity following dosing. Results will inform safe dosing and design of later trials in patients.

Who should consider this trial

Good fit: Healthy men aged 18–60 without recent heavy alcohol or drug use, limited cigarette use, no recent major surgery or significant blood loss, and no history of severe allergic reactions to monoclonal antibodies are ideal candidates.

Not a fit: People with active medical conditions, women (since only males are enrolled), heavy smokers, recent drug or alcohol users, recent major surgery or significant blood loss, or a history of severe allergic reactions to biologic drugs are unlikely to benefit from participation.

Why it matters

Potential benefit: If results are favorable, the data could define safe dose ranges and support further trials that may lead to treatments using CM559.

How similar studies have performed: Single-dose, dose-escalation Phase I trials in healthy volunteers are a standard first step for monoclonal antibodies and have previously defined safe dosing and PK for many antibody drugs, though efficacy must be shown in later patient trials.

Eligibility criteria

Inclusion Criteria:

* Subjects age ≥ 18 years \& ≤60 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 400mL, 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 3 months prior to screening,or planned surgery during the research period.

Where this trial is running

Chengdu, Sichuan

• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Qian Jia

Conditions Healthy Subjects