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Single Dose Escalation Study of CM383 in Healthy Volunteers

RECRUITINGPhase 1Sponsored by Keymed Biosciences Co.Ltd
Actively Recruiting
PhasePhase 1
SponsorKeymed Biosciences Co.Ltd
Started2024-05-28
Est. completion2025-06-30
Eligibility
Age18 Years – 80 Years
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06412185

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

Age: 18 Years – 80 YearsSex: MALEHealthy volunteers accepted
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.

Conditions2

Alzheimer DiseaseAlzheimer's Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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