Study of CM313 in Healthy Subjects

February 22, 2024 updated by: Keymed Biosciences Co.Ltd

A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

51

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
CM313, subcutaneous injection, once
Biological: CM313 injection
CM313
Experimental: Group 2
CM313, subcutaneous injection, once
Biological: CM313 injection
CM313
Experimental: Group 3
CM313, subcutaneous injection, once
Biological: CM313 injection
CM313
Experimental: Group 4
CM313, infusion, once
Biological: CM313 injection
CM313

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: Up to week 12
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keymed Biosciences Co.Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Estimated)

February 29, 2024

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CM313-100001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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