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Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM326 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM326 | Experimental | subcutaneous injection |
|
| Placebo | Placebo Comparator | subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326 | Drug | subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of CM326 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs | Day 1 through Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of CM326 | Serum concentrations of CM326 over time | Day 1 through Day 85 |
| Pharmacodynamics of CM326 | Serum total Immunoglobulin E (IgE) and Thymus and activation regulated chemokine (TARC) over time |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Hou | Peking University Care Luzhong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | Shandong | 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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| Drug |
subcutaneous injection |
|
| Day 1 through Day 85 |
| Immunogenicity | anti-drug antibody (ADA) | Day 1 through Day 85 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |