A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: CM326; Drug: Placebo

• Registration Number: NCT05171348
• Lead Sponsor: Keymed Biosciences Co.Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2021-12-28
• Study Start: 2022-01-07
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CM326 220mg Q4W	CM326	220mg for 3 doses, SC, Q4W
CM326 55mg Q2W	CM326	55mg for 6 doses, SC, Q2W
CM326 110mg Q2W	CM326	110mg for 6 doses, SC, Q2W
CM326 220mg Q2W	CM326	220mg for 6 doses, SC, Q2W
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
PK parameters: time to maximum concentration (Tmax).	up to Week 16	Time to maximum concentration (Tmax).
PK parameters: maximum concentration (Cmax).	up to Week 16	Maximum concentration (Cmax).
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).
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).
Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.	up to Week 16	Occurrence of anti-drug antibodies (ADA) to CM326.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China