Study of CM559 in Healthy Subjects

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.

Key facts

Study ID

NCT07175506

Run by

Keymed Biosciences Co.Ltd

People needed

40

Starts

2025-09-01

Expected to finish

2026-06-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Subjects age ≥ 18 years \& ≤60 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 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 it is running

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

Full record on ClinicalTrials.gov

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