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

NCT03858686 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-05-30

Study results available
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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.

Conditions

  • Asthma, COPD

Interventions

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.

Sponsors & Collaborators

  • Foresee Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zuzana Diamant, MD, PhD · QPS Netherlands

  • Rene Lutter · Academic Medical Centre/University of Amsterdam

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-02
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858686 on ClinicalTrials.gov