drugset
drugset / Trial / NCT05178355

A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers

NCT05178355 ↗

Phase 1 Completed 108 enrolled KalVista Pharmaceuticals, Ltd.
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety, tolerability, and pharmacokinetics of KVD824 following administration of single and multiple ascending oral doses; followed by a crossover food effect sub-study in healthy male volunteers.

Timeline

Start
2019-02-12
Primary completion
2019-06-21
Completion
2019-06-21

Drugs

EvaluationDrugModalityDoseRoute
Subject FENIRALSTAT Small molecule 10 mg Oral
Subject FENIRALSTAT Small molecule 20 mg Oral
Subject FENIRALSTAT Small molecule 40 mg Oral
Subject FENIRALSTAT Small molecule 80 mg Oral
Subject FENIRALSTAT Small molecule 160 mg Oral
Subject FENIRALSTAT Small molecule 320 mg Oral
Subject FENIRALSTAT Small molecule 640 mg Oral
Subject FENIRALSTAT Small molecule 1280 mg Oral

Indications

hereditary angioedema