A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: CM326

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qian Jia; Phone Number: +862888610620; Email: qianjia@keymedbio.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.	up to Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters: time to maximum concentration (Tmax).	Time to maximum concentration (Tmax).	up to Week 16
PK parameters: maximum concentration (Cmax).	Maximum concentration (Cmax).	up to Week 16
PK parameters: area under the plasma concentration-time curve over a dosing interval (AUCtau).	Area under the plasma concentration-time curve over a dosing interval (AUCtau).	up to Week 16
PK parameters: area under the plasma concentration-time curve from 0 to t (AUC0-t).	Area under the plasma concentration-time curve from 0 to t (AUC0-t).	up to Week 16
Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.	Occurrence of anti-drug antibodies (ADA) to CM326.	up to Week 16

Collaborators and Investigators

• Sponsor: Keymed Biosciences Co.Ltd

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): October 11, 2022
• Study Completion (Actual): October 11, 2022

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CM326HV002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No