Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose |
|
| Group 2 | Experimental | CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose |
|
| Group 3 | Experimental | CM326 220mg/2mL or matched placebo, subcutaneous at high dose |
|
| Group 4 | Experimental | CM326 220mg/2mL or matched placebo, subcutaneous at medium dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Biological | CM326 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emergency adverse events during treatment | By assessing the number and severity of adverse events during the study. | Up to week 12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jie Hou | Peking University Care Luzhong Hospital | Principal Investigator |
| Hong Wang | Peking University Care Luzhong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40185989 | Derived | Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Subcutaneous injection |
|