Single Ascending Dose Study of CM338 in Healthy Volunteers

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-11

Study Completion Date

2022-07-27

Brief Summary

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This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

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Detailed Description

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The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period.

Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.

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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CM338 30mg, IV

30mg, single dose, IV

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 60mg, IV

60mg, single dose, IV

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 120mg, IV

120mg, single dose, IV

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 240mg, IV

240mg, single dose, IV

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 240mg, SC

240mg, single dose, SC

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 480mg, IV

480mg, single dose, IV

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 600mg, IV

600mg, single dose, IV

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

CM338 600mg, SC

600mg, single dose, SC

Group Type EXPERIMENTAL

CM338

Intervention Type DRUG

CM338 : a humanized monoclonal antibody.

Placebo

Placebo, single dose, IV or SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo.

Interventions

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CM338

CM338 : a humanized monoclonal antibody.

Intervention Type DRUG

Placebo

Placebo.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* with the ability to understand this study and voluntarily sign the informed consent form.
* 18 to 65 years of age.
* with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
* able to communicate with the researchers and follow the requirements specified in the protocol.
* agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.

Exclusion Criteria

* plan to conduct any major surgery during the study.
* known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
* with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes