Actively Recruiting

Phase 1
Age: 18Years - 54Years
MALE
Healthy Volunteers
NCT07292688

Study of CM383 in Healthy Subjects

Led by Keymed Biosciences Co.Ltd · Updated on 2026-01-23

30

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.

CONDITIONS

Official Title

Study of CM383 in Healthy Subjects

Who Can Participate

Age: 18Years - 54Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male subjects aged 18 to 54 years
  • Voluntarily signed informed consent and able to follow study procedures
Not Eligible

You will not qualify if you...

  • Smoking more than 5 cigarettes per day within 3 months before screening
  • Heavy drinking within 3 months before screening, positive alcohol breath test, or inability to avoid alcohol during the study
  • History of drug abuse within 1 year before screening or positive drug screening
  • Blood donation or blood loss over 400 mL, or blood transfusion within 12 weeks before screening
  • Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibodies, other biological agents, or history of severe allergic reactions
  • Severe trauma or major surgery within 6 months before screening, or planned surgery during the study

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

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, China

Actively Recruiting

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Research Team

Q

Qian Jia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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