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Completed

NCT Number: NCT05171348

A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM326

Drug

a humanized monoclonal antibody

Placebo

Drug

Placebo

Primary outcomes

  1. Incidence of adverse events (AEs)

    Time frame: up to Week 24

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

Secondary outcomes

  1. PK parameters: time to maximum concentration (Tmax).

    Time frame: up to Week 16

    Time to maximum concentration (Tmax).

  2. PK parameters: maximum concentration (Cmax).

    Time frame: up to Week 16

    Maximum concentration (Cmax).

  3. PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau).

    Time frame: 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).

    Time frame: 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.

    Time frame: up to Week 16

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

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2021
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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