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Recruiting Phase 1 NCT06412185

Single Dose Escalation Study of CM383 in Healthy Volunteers

Trial Parameters

Condition Alzheimer Disease
Sponsor Keymed Biosciences Co.Ltd
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 56
Sex MALE
Min Age 18 Years
Max Age 80 Years
Start Date 2024-05-28
Completion 2025-06-30
Interventions
CM383Placebo

Brief Summary

This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.

Eligibility Criteria

Inclusion Criteria: * Healthy males, voluntarily participate; * 18 and 80 years old (including boundary values); * able to communicate well with the researchers and follow up the protocol requirements. Exclusion Criteria: * The average daily smoking volume within three months before screening is greater than 5 cigarettes; * Excessive alcohol consumption within three months before screening, or positive alcohol breath test; * Urine drug abuse screening is positive; * Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.

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