Status:
RECRUITING
Study of CM559 in Healthy Subjects
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Healthy Subjects
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
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, pharmac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07175506
Start Date
September 1 2025
End Date
June 1 2026
Last Update
September 29 2025
Active Locations (1)
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1
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China