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This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.
The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period.
Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM338 30mg, IV | Experimental | 30mg, single dose, IV |
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| CM338 60mg, IV | Experimental | 60mg, single dose, IV |
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| CM338 120mg, IV | Experimental | 120mg, single dose, IV |
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| CM338 240mg, IV | Experimental | 240mg, single dose, IV |
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| CM338 240mg, SC | Experimental | 240mg, single dose, SC |
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| CM338 480mg, IV | Experimental | 480mg, single dose, IV |
|
| CM338 600mg, IV |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM338 | Drug | CM338 : a humanized monoclonal antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety : Incidence of Adverse Events (AEs). | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Baseline up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) | Peak Plasma concentration (Cmax) | Baseline up to Day 57 |
| Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | Shandong | China |
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600mg, single dose, IV |
|
| CM338 600mg, SC | Experimental | 600mg, single dose, SC |
|
| Placebo | Placebo Comparator | Placebo, single dose, IV or SC |
|
| Placebo | Drug | Placebo. |
|
Time to reach peak concentration (Tmax)
| Baseline up to Day 57 |
| Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞) | Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞) | Baseline up to Day 57 |
| Pharmacokinetics (PK) parameter : 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) | Baseline up to Day 57 |
| Pharmacokinetics (PK) parameter : Clearance rate (CL/F) | Clearance rate (CL/F) | Baseline up to Day 57 |
| Bioavailability : bioavailability of CM338 with SC | The bioavailability of CM338 with SC | Baseline up to Day 57 |
| Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum. | C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum. | Baseline up to Day 57 |
| Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum. | The content of mannose-binding lectin serine protease 2 (MASP-2) in serum. | Baseline up to Day 57 |
| Immunogenicity: Proportion of subjects with anti-drug antibody (ADA). | Proportion of subjects with anti-drug antibody (ADA). | Baseline up to Day 57 |