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OpenTrials
Completed

NCT Number: NCT05715333

Study of CM326 Injection in Healthy Subjects

This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.

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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

About this study

The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥18 years and ≤ 65 years, healthy male.
  • With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
  • Subjects can communicate well with investigators and comply with protocol requirements.

Exclusion criteria

  • Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
  • Major surgery is planned during the study period.
  • The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
  • Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
  • There are any reasons that the investigator believes will prevent the subject from participating in the study.

Treatment and study plan

CM326

Biological

CM326 Injection

Placebo

Other

Subcutaneous injection

Primary outcomes

  1. Emergency adverse events during treatment

    Time frame: Up to week 12

    By assessing the number and severity of adverse events during the study.

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Immunogenicity of CM326 Injection in Healthy Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Nov 8, 2024

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.

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