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This is a Phase I, first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of ascending doses of CBP-4888.
This study will involve female subjects meeting all inclusion criteria and no exclusion criteria. Cohorts of CBP-4888 are planned to be investigated in a sequential dose-escalation manner. Each cohort of subjects will be randomized to CBP-4888 to placebo and administered a single subcutaneous dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBP-4888 | Experimental | CBP-4888 administered once as a subcutaneous dose. |
|
| Placebo | Placebo Comparator | Normal Saline administered once as a subcutaneous dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBP-4888 | Drug | siRNA therapeutic |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of participants with treatment-related adverse events | 30 days |
| Pain at Site of Injection | Assessment of Pain on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 days |
| Tenderness at Site of Injection | Assessment of Tenderness on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 Days |
| Erythema at Site of Injection | Assessment of Erythema on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 days |
| Swelling at Site of Injection | Assessment of Swelling on a 5 point scale (none, mild, moderate, severe or potentially life threatening) | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of CBP-4888 | Peak Plasma Concentration | 30 days |
| AUC of CBP-4888 | Area Under the Plasma Concentration Versus Time Curve | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics | Concentraion of sFLt-1 | 30 days |
Inclusion Criteria:
Exclusion Criteria:
females
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| Name | Affiliation | Role |
|---|---|---|
| Allison August, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comanche Biopharma Clinical Research Site #1 | San Antonio | Texas | 78217 | United States |
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| Other |
Normal Saline |
|
| Tmax of CBP-4888 | Time to maximum plasma concentration | 30 days |