Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

October 14, 2024 updated by: Keymed Biosciences Co.Ltd

A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

240

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 Locations

  • China
      • Zibo, China
        • PKUcare Luzhong Hospital

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have the ability to understand the study.
  • Voluntarily participate in the study and sign the ICF.
  • 18 years ≤ age ≤ 65 years, male and female.
  • Willing to take effective contraceptive measures during the study period.

Exclusion Criteria:

  • Plan to receive any major surgery during the study period.
  • With malignant tumors within 5 years before screening.
  • Positive results of alcohol breath test or urine drug abuse screening during screening period.
  • Any reason that the investigator believes that will prevent the subject from participating in the 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 P1
CM310, Subcutaneous
Biological: CM310
CM310 Recombinant Humanized Monoclonal Antibody Injection
Active Comparator: Group P2
CM310, Subcutaneous, as the parallel control group
Biological: CM310
CM310 Recombinant Humanized Monoclonal Antibody Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic: the maximum concentration (Cmax)
Time Frame: up to 57 days
Concentration and exposure
up to 57 days

Collaborators and Investigators

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

Sponsor

Keymed Biosciences Co.Ltd

Investigators

  • Principal Investigator: Hong Wang, Peking University Care Luzhong Hospital
  • Principal Investigator: Jie Hou, Peking University Care Luzhong Hospital

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 (Actual)

March 22, 2023

Primary Completion (Actual)

July 26, 2023

Study Completion (Actual)

July 26, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 14, 2024

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CM310-100002

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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