Study of CM326 Injection in Healthy Subjects

November 7, 2024 updated by: Keymed Biosciences Co.Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zibo, China
        • PKUCare Luzhong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose
Other: Placebo
Subcutaneous injection
Biological: CM326
CM326 Injection
Experimental: Group 2
CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose
Other: Placebo
Subcutaneous injection
Biological: CM326
CM326 Injection
Experimental: Group 3
CM326 220mg/2mL or matched placebo, subcutaneous at high dose
Other: Placebo
Subcutaneous injection
Biological: CM326
CM326 Injection
Experimental: Group 4
CM326 220mg/2mL or matched placebo, subcutaneous at medium dose
Other: Placebo
Subcutaneous injection
Biological: CM326
CM326 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency adverse events during treatment
Time Frame: Up to week 12
By assessing the number and severity of adverse events during the study.
Up to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Hong Wang, Peking University Care Luzhong Hospital
  • Principal Investigator: Jie Hou, Peking University Care Luzhong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Actual)

October 4, 2023

Study Completion (Actual)

October 4, 2023

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CM326-100003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe