Actively Recruiting

Phase 1
Age: 18Years - 60Years
MALE
Healthy Volunteers
NCT07175506

Study of CM559 in Healthy Subjects

Led by Keymed Biosciences Co.Ltd · Updated on 2025-09-29

40

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.

CONDITIONS

Official Title

Study of CM559 in Healthy Subjects

Who Can Participate

Age: 18Years - 60Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 60 years
  • Voluntarily signed informed consent and able to follow study rules
Not Eligible

You will not qualify if you...

  • Smoking more than 5 cigarettes per day in the last 3 months
  • Heavy alcohol use in the last 3 months, inability to avoid alcohol during study, or positive alcohol breath test
  • History of drug abuse within 1 year or positive urine drug screening
  • Blood loss over 400 mL or blood transfusion within 12 weeks before screening
  • Suspected allergy to Ab2-antibody drugs, humanized monoclonal antibodies, biological agents, or history of severe drug allergy
  • Severe trauma or major surgery within 3 months before screening, or planned surgery during 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

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Actively Recruiting

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Research Team

Q

Qian Jia

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

5

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Study of CM559 in Healthy Subjects | DecenTrialz