Study of CM326 Injection in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: CM326; Other: Placebo

• Registration Number: NCT05715333
• Lead Sponsor: Keymed Biosciences Co.Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-08
• Status Verified: 2023-03
• Study Start: 2023-03-21
• Primary Completion: 2023-10-04
• Study Completion: 2023-10-04
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 3	CM326	CM326 220mg/2mL or matched placebo, subcutaneous at high dose
Group 1	CM326	CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose
Group 1	Placebo	CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose
Group 2	CM326	CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose
Group 2	Placebo	CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose
Group 3	Placebo	CM326 220mg/2mL or matched placebo, subcutaneous at high dose
Group 4	CM326	CM326 220mg/2mL or matched placebo, subcutaneous at medium dose
Group 4	Placebo	CM326 220mg/2mL or matched placebo, subcutaneous at medium dose

Primary Outcome Measures

Name	Time	Method
Emergency adverse events during treatment	Up to week 12	By assessing the number and severity of adverse events during the study.

Trial Locations

Locations (1)

PKUCare Luzhong Hospital; 🇨🇳 Zibo, China