drugset / Trial / NCT03879278
Multiple Ascending Dose Study in Healthy Subjects
RandomizedParallel-groupTriple-blindTreatment
Summary
This will be a Phase 1, randomized, double-blind, single center, placebo-controlled, multiple ascending dose (MAD) study in a maximum of 3 cohorts of 8 healthy male and female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple IV doses of NPT189 or matching placebo.
Timeline
- Start
- 2019-03-06
- Primary completion
- 2019-06-27
- Completion
- 2019-06-27
Outcome
Outcome not reported
Stopped: “Mild infusion reactions were observed in two healthy volunteers.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NPT189 | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | NPT189 | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Subject | NPT189 | Protein / enzyme biologic | 12.5 mg/kg | Intravenous |