A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05171348
• Other study ID #: CM326HV002
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2022
• Est. completion date: October 11, 2022

Study information

• Verified date: December 2021
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• CM326
a humanized monoclonal antibody
• Placebo
Placebo

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK parameters: time to maximum concentration (Tmax).	Time to maximum concentration (Tmax).	up to Week 16
Secondary	PK parameters: maximum concentration (Cmax).	Maximum concentration (Cmax).	up to Week 16
Secondary	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
Secondary	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
Secondary	Immunogenicity endpoints: Occurrence of anti-drug antibodies (ADA) to CM326.	Occurrence of anti-drug antibodies (ADA) to CM326.	up to Week 16