Study of CM326 Injection in Healthy Subjects

• Sponsor: Keymed Biosciences Co.Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05715333
• Collaborator: (none)
• Enrollment: 46
• Arms: 3
• Anticipated Duration (Months): 11.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: CM326	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Mar 30, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CM326 Low Dose CM326 220 mg/2 mL, subcutaneous at low dose	Biological: CM326; CM326 Injection
Experimental: CM326 Medium Dose CM326 220mg/2 mL, subcutaneous at medium dose	Biological: CM326; CM326 Injection
Experimental: CM326 High Dose CM326 220mg/2mL, subcutaneous at high dose	Biological: CM326; CM326 Injection

Outcome Measures

Primary Outcome Measures

1. Emergency adverse events during treatment [Up to week 12]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Keymed Biosciences Co.Ltd
• ClinicalTrials.gov Identifier: NCT05715333
• Other Study ID Numbers: CM326-100003
• First Posted: Feb 8, 2023
• Last Update Posted: Feb 8, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 8, 2023