Actively Recruiting

Phase 1
Age: 18Years - 80Years
MALE
Healthy Volunteers
NCT06412185

Single Dose Escalation Study of CM383 in Healthy Volunteers

Led by Keymed Biosciences Co.Ltd · Updated on 2024-11-08

56

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Single Dose Escalation Study of CM383 in Healthy Volunteers

Who Can Participate

Age: 18Years - 80Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy males who voluntarily agree to participate
  • Between 18 and 80 years old (inclusive)
  • Able to communicate well with researchers and follow study requirements
Not Eligible

You will not qualify if you...

  • Smoking more than 5 cigarettes daily on average within 3 months before screening
  • Excessive alcohol use within 3 months before screening or positive alcohol breath test
  • Positive urine drug abuse screening
  • Planning family or sperm donation or unwilling to use effective contraception

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jinan Central Hospital

Jinan, Shandong, China

Actively Recruiting

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Research Team

Q

Qian Jia

CONTACT

Q

Qing Wen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

6

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Single Dose Escalation Study of CM383 in Healthy Volunteers | DecenTrialz