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Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects

NCT04032535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-02-13

No results posted yet for this study

Summary

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF6523 DPI in healthy male subjects first and then in COPD subjects after single or repeated dosesof CHF6523. As an exploratory assessment, the anti-inflammatory effect of CHF6523 in COPDsubjects will be evaluated.

Conditions

Interventions

DRUG

CHF6523

CHF6523 is a PI3K inhibitor (phosphoinositide3-kinase)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jorg Taubel, MD · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2022-12-05
Completion
2022-12-05

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04032535 on ClinicalTrials.gov