Study of CM326 Injection in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-21

Study Completion Date

2023-10-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

CM326

Intervention Type BIOLOGICAL

CM326 Injection

Placebo

Intervention Type OTHER

Subcutaneous injection

Group 2

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

Group Type EXPERIMENTAL

CM326

Intervention Type BIOLOGICAL

CM326 Injection

Placebo

Intervention Type OTHER

Subcutaneous injection

Group 3

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

Group Type EXPERIMENTAL

CM326

Intervention Type BIOLOGICAL

CM326 Injection

Placebo

Intervention Type OTHER

Subcutaneous injection

Group 4

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

Group Type EXPERIMENTAL

CM326

Intervention Type BIOLOGICAL

CM326 Injection

Placebo

Intervention Type OTHER

Subcutaneous injection

Interventions

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CM326

CM326 Injection

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes