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A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

Sponsor
Keymed Biosciences Co.Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05171348
Collaborator
(none)
40
Enrollment
1
Location
5
Arms
11.8
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center, randomized, double-blind, placebo-controlled, dose-escalating study to evaluate the safety, tolerability, PK profile, and immunogenicity of multiple SC administraion of CM326 at different doses in healthy subjects.

40 healthy male subjects will be enrolled in the study. The drug will be administered by dose-escalating principle at 4 dose levels: 55 mg Q2W, 110 mg Q2W, 220 mg Q2W, 220 mg Q4W.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Multiple Ascending Doses of CM326 Injection by Subcutaneous Administration in Healthy Subjects
Actual Study Start Date :
Jan 7, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CM326 55mg Q2W

55mg for 6 doses, SC, Q2W

Drug: CM326
a humanized monoclonal antibody
Experimental: CM326 110mg Q2W

110mg for 6 doses, SC, Q2W

Drug: CM326
a humanized monoclonal antibody
Experimental: CM326 220mg Q2W

220mg for 6 doses, SC, Q2W

Drug: CM326
a humanized monoclonal antibody
Experimental: CM326 220mg Q4W

220mg for 3 doses, SC, Q4W

Drug: CM326
a humanized monoclonal antibody
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events (AEs) [up to Week 24]

    Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

Secondary Outcome Measures

  1. PK parameters: time to maximum concentration (Tmax). [up to Week 16]

    Time to maximum concentration (Tmax).

  2. PK parameters: maximum concentration (Cmax). [up to Week 16]

    Maximum concentration (Cmax).

  3. PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau). [up to Week 16]

    Area under the plasma concentration-time curve over a dosing interval (AUCtau).

  4. PK parameters: area under the plasma concentration-time curve from 0 to t (AUC0-t). [up to Week 16]

    Area under the plasma concentration-time curve from 0 to t (AUC0-t).

  5. Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326. [up to Week 16]

    Occurrence of anti-drug antibodies (ADA) to CM326.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Male healthy volunteers, aged between 18 and 65 years of age inclusive, with a body mass index (BMI) within 18-26 kg/m2 (inclusive);

  • Medical history, vital signs, physical examination, 12-lead Electrocardiogram, chest X-ray and abdominal color ultrasound are normal or abnormal with no clinical significance;

  • All variables of clinical laboratory tests are normal or abnormal with no clinical significance;

  • Subjects and partners agree to take effective contraception throughout the study (from screening to 3 months after the end of treatment);

  • Capable of understanding the nature of the study and voluntarily signing the Informed Consent Form.

Exclusion Criteria:

  • Known allergy to monoclonal antibody drugs or other related drugs, or allergy to excipients of CM326 injection;

  • History of any clinically serious disease or history of circulatory, endocrine, neurological or hematological, immune, psychiatric, and metabolic diseases;

  • History of asthma and allergic reactions;

  • Use of any prescription drugs within 2 weeks prior to dosing, use of traditional Chinese medicine or over-the-counter drugs within 1 week prior to dosing;

  • Received any marketed or investigational biologics within 5 half-lives (if known) or 12 weeks (whichever is longer) prior to dosing, or any investigational non-biologics within 5 half-lives (if known) or 4 weeks (whichever is longer) prior to dosing.

Contacts and Locations

Locations

Site City State Country Postal Code
1 West China Hospital of Sichuan University Chengdu Sichuan China

Sponsors and Collaborators

  • Keymed Biosciences Co.Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Keymed Biosciences Co.Ltd
ClinicalTrials.gov Identifier:
NCT05171348
Other Study ID Numbers:
  • CM326HV002
First Posted:
Dec 28, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 9, 2022