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Single Ascending Dose Study of CM326 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04842201
Recruitment Status : Active, not recruiting
First Posted : April 13, 2021
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Keymed Biosciences Co.Ltd

Study Description
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Brief Summary:
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Asthma Drug: CM326 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Placebo-Controlled, Double-blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CM326 in Adult Healthy Volunteers
Actual Study Start Date : April 16, 2021
Actual Primary Completion Date : September 28, 2021
Estimated Study Completion Date : February 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: CM326
subcutaneous injection
 Drug: CM326
subcutaneous injection
Placebo Comparator: Placebo
subcutaneous injection
 Drug: Placebo
subcutaneous injection


Outcome Measures
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Primary Outcome Measures :
  1. Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs [ Time Frame: Day 1 through Day 85 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of CM326 [ Time Frame: Day 1 through Day 85 ]
    Serum concentrations of CM326 over time

  2. Pharmacodynamics of CM326 [ Time Frame: Day 1 through Day 85 ]
    Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time

  3. Immunogenicity [ Time Frame: Day 1 through Day 85 ]
    anti-drug antibody (ADA)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Healthy adult male participant,18 to 65 years of age, inclusive.
  • Body Mass Index (BMI) 18 to 26 kg/m2, inclusive.
  • History, physical examination, laboratory tests and test related items of inspection were normal or abnormal without clinically insignificant.
  • Males must abstain from sex or use highly effective methods of birth control.
  • Having given written informed consent prior to undertaking any study-related procedure.

Key Exclusion Criteria:

  • Positive for HIV, or Hepatitis B, or C.
  • Positive result on urine drug screen.
  • Clinical laboratory abnormalities of clinical significance, or other clinical findings suggest clinically significant following diseases (including, but not limited to the gastrointestinal tract, kidney, liver, nerve, blood, endocrine, cancer, lung, immune, mental or cardiovascular disease).
  • With any condition that inappropriate for entry into this study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842201


Locations
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China, Shandong
PKUCare Luzhong Hospital
Zibo, Shandong, China
Sponsors and Collaborators
Keymed Biosciences Co.Ltd
Investigators
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Principal Investigator: Jie Hou PKUcare luzhong hospital
More Information
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Responsible Party: Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier: NCT04842201    
Other Study ID Numbers: CM326HV001
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No