Study of CM326 Injection in Healthy Subjects

Keymed Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Placebo; Biological: CM326

Study type: Interventional

Funder types: Industry

Identifiers

NCT05715333

CM326-100003

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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46 participants in 4 patient groups

Group 1

Experimental group

Description:

CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose

Treatment:

Biological: CM326

Other: Placebo

Group 2

Experimental group

Description:

CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose

Treatment:

Biological: CM326

Other: Placebo

Group 3

Experimental group

Description:

CM326 220mg/2mL or matched placebo, subcutaneous at high dose

Treatment:

Biological: CM326

Other: Placebo

Group 4

Experimental group

Description:

CM326 220mg/2mL or matched placebo, subcutaneous at medium dose

Treatment:

Biological: CM326

Other: Placebo