drugset / Trial / NCT03522935
Subcutaneous Elafin in Healthy Subjects
Phase 1
Completed
30 enrolled
Roham T. Zamanian
Duke University · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabSRI International · collab
RandomizedSequentialDouble-blindTreatment
Summary
A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult subjects. The purpose of this study is to assess Elafin that is being developed for treatment of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and is a major factor in the development of PAH. Elafin will be administered subcutaneously daily for 7 days in normal healthy subjects followed over a 28 day time period.
Timeline
- Start
- 2019-03-18
- Primary completion
- 2019-10-25
- Completion
- 2020-11-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Elafin | Unknown | 0.03 mg/kg | Subcutaneous |
| Subject | Elafin | Unknown | 0.06 mg/kg | Subcutaneous |
| Subject | Elafin | Unknown | 0.1 mg/kg | Subcutaneous |
| Subject | Elafin | Unknown | 0.15 mg/kg | Subcutaneous |
| Subject | Elafin | Unknown | 0.18 mg/kg | Subcutaneous |