A Multiple Ascending Doses Study of CM326 Injection in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Drug: CM326
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM326 55mg Q2W<br>55mg for 6 doses, SC, Q2W | Drug: CM326<br>* a humanized monoclonal antibody<br>|
| Experimental: CM326 110mg Q2W<br>110mg for 6 doses, SC, Q2W | Drug: CM326<br>* a humanized monoclonal antibody<br>|
| Experimental: CM326 220mg Q2W<br>220mg for 6 doses, SC, Q2W | Drug: CM326<br>* a humanized monoclonal antibody<br>|
| Experimental: CM326 220mg Q4W<br>220mg for 3 doses, SC, Q4W | Drug: CM326<br>* a humanized monoclonal antibody<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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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 |