drugset / Trial / NCT05490017

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104

NCT05490017 ↗

Phase 1 Completed 80 enrolled Kira Pharmacenticals (US), LLC.
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

EvaluationDrugModalityDoseRoute
Subject VENSOBAFUSP ALFA Protein / enzyme biologic — Intravenous