Study of CM313 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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-12

Study Completion Date

2025-04-30

Brief Summary

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This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.

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Detailed Description

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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

CM313, subcutaneous injection, once

Group Type EXPERIMENTAL

CM313 injection

Intervention Type BIOLOGICAL

CM313

Group 2

CM313, subcutaneous injection, once

Group Type EXPERIMENTAL

CM313 injection

Intervention Type BIOLOGICAL

CM313

Group 3

CM313, subcutaneous injection, once

Group Type EXPERIMENTAL

CM313 injection

Intervention Type BIOLOGICAL

CM313

Group 4

CM313, infusion, once

Group Type EXPERIMENTAL

CM313 injection

Intervention Type BIOLOGICAL

CM313

Interventions

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CM313 injection

CM313

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects age ≥ 18 years \& ≤50 years.
* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion Criteria

* With history of malignant tumors;
* Plan to undergo major surgery during the research period
* Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
* With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
* The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
* Positive results in baseline alcohol breath test or urine drug abuse screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes