Single Ascending Dose Study of CM338 in Healthy Volunteers

November 7, 2024 updated by: Keymed Biosciences Co.Ltd

A Single-dose, Randomized, Double Blind, Placebo-controlled, Dose-increasing Study to Evaluate the Safety, Tolerability, PK Characteristics, PD Effect, and Immunogenicity of CM338 Injection in Healthy Subjects.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Zibo, Shandong, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CM338 30mg, IV
30mg, single dose, IV
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 60mg, IV
60mg, single dose, IV
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 120mg, IV
120mg, single dose, IV
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 240mg, IV
240mg, single dose, IV
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 240mg, SC
240mg, single dose, SC
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 480mg, IV
480mg, single dose, IV
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 600mg, IV
600mg, single dose, IV
Drug: CM338
CM338 : a humanized monoclonal antibody.
Experimental: CM338 600mg, SC
600mg, single dose, SC
Drug: CM338
CM338 : a humanized monoclonal antibody.
Placebo Comparator: Placebo
Placebo, single dose, IV or SC
Drug: Placebo
Placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety : Incidence of Adverse Events (AEs).
Time Frame: Baseline up to Day 57
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Baseline up to Day 57

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Time Frame: Baseline up to Day 57
Peak Plasma concentration (Cmax)
Baseline up to Day 57
Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)
Time Frame: Baseline up to Day 57
Time to reach peak concentration (Tmax)
Baseline up to Day 57
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Time Frame: Baseline up to Day 57
Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Baseline up to Day 57
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Time Frame: Baseline up to Day 57
Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Baseline up to Day 57
Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
Time Frame: Baseline up to Day 57
Clearance rate (CL/F)
Baseline up to Day 57
Bioavailability : bioavailability of CM338 with SC
Time Frame: Baseline up to Day 57
The bioavailability of CM338 with SC
Baseline up to Day 57
Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.
Time Frame: Baseline up to Day 57
C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.
Baseline up to Day 57
Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum.
Time Frame: Baseline up to Day 57
The content of mannose-binding lectin serine protease 2 (MASP-2) in serum.
Baseline up to Day 57
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).
Time Frame: Baseline up to Day 57
Proportion of subjects with anti-drug antibody (ADA).
Baseline up to Day 57

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM338HV001

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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