Multiple Ascending Dose Study of CM338 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

Detailed Description
-----------------
The study included screening period, administration and safety follow-up period. Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Official Title
-----------------
A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Biological: CM338 Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers, aged ≥18 and ≤65 years. Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance. All clinical laboratory examination are normal, or abnormal without clinical significance. Exclusion Criteria: Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week. Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period. Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing. Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM338 75 mg, subcutaneous injection<br>Qquaque week | Biological: CM338 Injection<br>* A humanized monoclonal antibody.<br>|
| Experimental: CM338 150 mg, subcutaneous injection<br>Qquaque week | Biological: CM338 Injection<br>* A humanized monoclonal antibody.<br>|
| Experimental: CM338 300 mg, subcutaneous injection<br>Qquaque week | Biological: CM338 Injection<br>* A humanized monoclonal antibody.<br>|
| Experimental: CM338 300 mg, intravenous infusion<br>Qquaque week | Biological: CM338 Injection<br>* A humanized monoclonal antibody.<br>|
| Placebo Comparator: Placebo<br>placebo | Biological: CM338 Injection<br>* A humanized monoclonal antibody.<br>|

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 12. |