drugset / Trial / NCT03651089
SP16 SERPIN-like Peptide Administration in Healthy Individuals
Phase 1
Completed
24 enrolled
Serpin Pharma, LLC
George Mason University · collabVirginia Commonwealth University · collab
RandomizedSequentialTriple-blindTreatment
Summary
This study is a randomized, double-blind, placebo-controlled Phase 1 Clinical Trial of 24 healthy individuals to test the safety, tolerability and pharmacokinetics of a single subcutaneous administration of Serpin Peptide 16 (SP16), a Serine Protease Inhibitor (Serpin)-like, small peptide agonist of the Low Density Lipoprotein Receptor-like Protein 1 (LRPP1) hypothesized to have anti-inflammatory activity.
Timeline
- Start
- 2018-07-16
- Primary completion
- 2019-01-15
- Completion
- 2019-01-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | SP16 | Peptide | 0.0125 mg/kg | Subcutaneous |
| Comparator | SP16 | Peptide | 0.05 mg/kg | Subcutaneous |
| Comparator | SP16 | Peptide | 0.2 mg/kg | Subcutaneous |
Indications
No indication recorded.