drugset / Trial / NCT05490017
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104
RandomizedSequentialQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of KP104 and Part 2, multiple ascending dose (MAD).
Timeline
- Start
- 2020-12-30
- Primary completion
- 2022-05-04
- Completion
- 2022-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VENSOBAFUSP ALFA | Protein / enzyme biologic | — | Intravenous |