NCT03858686

The Effect of FP-025, on Allergen-induced Airway Responses in Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma.

The Effect of FP-025, a MMP-12 Inhibitor, on Allergen-induced Airway Responses, Airway Inflammation and Aspects of Airway Remodeling in Subjects With Mild Eosinophilic House Dust Mite (HDM)-Allergic Asthma (HDM)-Allergic Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover, 2-center (conducted in EU; The Netherlands) study in male and female subjects with stable, mild HDM-allergic asthma.

Detailed description

This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover, 2-center (conducted in EU; The Netherlands) study in male and female subjects with stable, mild HDM-allergic asthma. The study will consist of two identical study periods of 12 treatment days each, separated by a washout period of at least 3 weeks (and no more than 7 weeks). Approximately 36 eligible subjects will be enrolled, to yield 32 evaluable subjects who will be treated with both FP-025 (400 mg BID) or matching placebo in a cross-over design from the evening of Day 1 till the morning of Day 12 (22 doses per study period in total).

Conditions

• Asthma, COPD

Interventions

Type	Name	Description
DRUG	FP-025 capsules	FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
DRUG	Placebo FP-025 capsules	Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.

Timeline

• Start date: 2018-07-02
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-03-01
• Last updated: 2024-05-30
• Results posted: 2024-05-30

Locations

2 sites across 1 country: Netherlands

Regulatory

• FDA-regulated drug study