Study of CM326 Injection in Healthy Subjects

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: Healthy
• Intervention / Treatment: Other: Placebo; Biological: CM326

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

Study Locations

• China
  • Zibo, China
    • PKUcare Luzhong Hospital

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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	By assessing the number and severity of adverse events during the study.	Up to week 12

Collaborators and Investigators

• 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

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