NCT05178355

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

A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Doses Study of the Safety, Tolerability, and Pharmacokinetics of KVD824 Followed by Crossover Food Effect Sub-study in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: KalVista Pharmaceuticals, Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part A was a single-centre randomized, double blinded, placebo control to investigate the safety and tolerability of single ascending doses of KVD824 administered to healthy male volunteers. Part B was a single centre, randomized, double blinded, placebo control to investigate the safety and tolerability of multiple ascending doses of KVD824 administered to healthy male volunteers. Part C was a single-centre, open labelled to investigate the food effect.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	KVD824	Active
DRUG	Placebo to KVD824	Placebo

Timeline

• Start date: 2019-02-12
• Primary completion: 2019-06-21
• Completion: 2019-06-21
• First posted: 2022-01-05
• Last updated: 2022-02-17

Locations

1 site across 1 country: United Kingdom