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, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | CM313, subcutaneous injection, once |
|
| Group 2 | Experimental | CM313, subcutaneous injection, once |
|
| Group 3 | Experimental | CM313, subcutaneous injection, once |
|
| Group 4 | Experimental | CM313, infusion, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM313 injection | Biological | CM313 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | Up to week 12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Qing Zhang | Huashan Hospital | Principal Investigator |
| Yu Xue | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40965985 | Derived | Yu S, Wu J, Zhao J, He J, Yan H, Zhang X, Yang Y, Song H, Hou Q, Guo B, Qiu Y, Chen B, Xue Y, Zhang J. Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. Clin Transl Sci. 2025 Sep;18(9):e70334. doi: 10.1111/cts.70334. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided