RecruitingPhase 1NCT06412185

Single Dose Escalation Study of CM383 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

56 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

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

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

Healthy males, voluntarily participate;
and 80 years old (including boundary values);
able to communicate well with the researchers and follow up the protocol requirements.

Exclusion Criteria4

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.