Study of CM326 Injection in Healthy Subjects

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715333
• Other study ID #: CM326-100003
• Status: Recruiting
• Phase: Phase 1
• Start date: March 21, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2023
• Source: Keymed Biosciences Co.Ltd
• Contact: Qian Jia
• Phone: 028-88610620
• Email: qianjia[@]keymedbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CM326
CM326 Injection

Other:
• Placebo
Subcutaneous injection

Locations

Country	Name	City	State
China	PKUCare Luzhong Hospital	Zibo

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emergency adverse events during treatment	By assessing the number and severity of adverse events during the study.	Up to week 12