Skip to main content
OpenTrials
Completed

NCT Number: NCT06161090

Study of CM310 in Healthy Subjects

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PKUCare Luzhong Hospital

Zibo, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers.
  • aged ≥ 18 and ≤ 65 years old.
  • With all clinical laboratory examination normal.
  • Voluntary signing of the informed consent form.

Exclusion criteria

  • With a history of asthma and allergic reactions.
  • With a history of conjunctivitis and keratitis, as well as previous medical conditions.
  • With positive results from alcohol breath or urine drug abuse testing.

Treatment and study plan

CM310

Biological

CM310 injection

Placebo

Drug

subcutaneous injection

Primary outcomes

  1. Adverse event

    Time frame: up to Week 9

    Incidence of adverse events.

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.