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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM326 55mg Q2W | Experimental | 55mg for 6 doses, SC, Q2W |
|
| CM326 110mg Q2W | Experimental | 110mg for 6 doses, SC, Q2W |
|
| CM326 220mg Q2W | Experimental | 220mg for 6 doses, SC, Q2W |
|
| CM326 220mg Q4W | Experimental | 220mg for 3 doses, SC, Q4W |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Drug | a humanized monoclonal antibody |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Placebo | Drug | Placebo |
|
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |