Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

December 6, 2023 updated by: Keymed Biosciences Co.Ltd

A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study includes screening and treatment and follow-up periods.

Study Type

Interventional

Enrollment (Estimated)

236

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Wei Hu

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:

  • 20 years ≤ age ≤ 45 years.
  • Voluntarily participate in the study and sign the ICF.
  • Have the ability to understand the study.

Exclusion Criteria:

  • With history of chronic or serious illness.
  • With any medication within 28 days prior to administration;
  • Plan to undergo surgery during the research period;
  • With any situations unsuitable to participate in this study.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
CM310 injection, Subcutaneous
Biological: CM310
CM310 injection
Experimental: Group B
CM310 injection, Subcutaneous
Biological: CM310
CM310 injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic: the maximum concentration (Cmax)
Time Frame: up to week 6
Concentration and exposure
up to week 6

Collaborators and Investigators

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

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Wei Hu, The Second Hospital of Anhui Medical University

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

December 5, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Estimated)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CM310-100005

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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