drugset / Trial / NCT05387499
A Study of NP-011 in Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetic of NP-011 in healthy volunteers.
Timeline
- Start
- 2022-06-10
- Primary completion
- 2023-03-07
- Completion
- 2023-05-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NP-011 | Protein / enzyme biologic | 250 ug | Intravenous |
| Subject | NP-011 | Protein / enzyme biologic | 500 ug | Intravenous |
| Subject | NP-011 | Protein / enzyme biologic | 1000 ug | Intravenous |
| Subject | NP-011 | Protein / enzyme biologic | 2000 ug | Intravenous |
| Subject | NP-011 | Protein / enzyme biologic | 4000 ug | Intravenous |