NCT05006521

Single and Multiple Ascending Dose Study of KN-002

Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, PK, and PD of Single Ascending Doses of KN-002 in Healthy Subjects and Multiple Ascending Doses of KN-002 in Subjects With Mild Asthma, Moderate-Severe Asthma and COPD

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Kinaset Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 4 parts: Part 1 is a single ascending dose (SAD) study in healthy volunteers; Part 2 is a multiple ascending dose (MAD) study in subjects with stable, mild asthma; Part 3 is a repeat dose in patients with moderate to severe asthma and Part 4 is a repeat dose in patients with COPD.

Conditions

• Asthma COPD

Interventions

Type	Name	Description
DRUG	KN-002	KN-002 dry powder inhaler

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-12-20
• Completion: 2024-07-25
• First posted: 2021-08-16
• Last updated: 2024-08-07

Locations

1 site across 1 country: United Kingdom