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This is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (SC) or intravenous (IV) administration of STAR-0215 in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STAR-0215 Dose 1 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. |
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| STAR-0215 Dose 2 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. |
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| STAR-0215 Dose 3 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. |
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| STAR-0215 Dose 4 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. |
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| STAR-0215 Dose 5 | Experimental | Participants will be randomized to receive STAR-0215 or placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STAR-0215 (SC) | Drug | STAR-0215 will be administered as an SC bolus injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-emergent Adverse Events | Day 1 through Day 224 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of STAR-0215 | Blood samples will be collected to measure the serum concentration of STAR-0215 before and after study drug administration. | Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Clinical Research, LLC | West Bend | Wisconsin | 53095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40158724 | Derived | Lumry W, Gunsior M, Cohen T, Bernard K, Gustafson P, Chung JK, Morabito C. Safety and pharmacokinetics of long-acting plasma kallikrein inhibitor navenibart (STAR-0215) in healthy adults. Ann Allergy Asthma Immunol. 2025 Jul;135(1):103-111.e2. doi: 10.1016/j.anai.2025.03.016. Epub 2025 Mar 28. |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
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| Placebo (SC) | Drug | Placebo will be administered as an SC bolus injection. |
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| STAR-0215 (IV) | Drug | STAR-0215 will be administered as an IV bolus injection. |
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| Placebo (IV) | Drug | Placebo will be administered as an IV bolus injection. |
|
| Plasma Levels of Cleaved High-molecular-weight Kininogen |
Blood samples will be collected to measure the plasma levels of cleaved high-molecular-weight kininogen (a measure of plasma kallikrein activity). |
| Day 1 (pre-dose, up to 2 hours before study drug administration, and 2, 6, 12, 24, 48, 72, 96, and 120 hours post-dose); Days 14, 28, 56, 84, 112, 140, 168, 196, and 224 |
| Number of Participants with Anti-drug Antibodies to STAR-0215 | Blood samples will be collected to assess the formation of STAR-0215 anti-drug antibodies in serum before and after study drug administration. | Day 1 (pre-dose, up to 2 hours before study drug administration); Days 28, 56, 84, 112, 140, 168, 196, and 224 |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |