MedTrace Logo

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of CHF6297 in Healthy Subjects and Patients With COPD

NCT02815488 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-04-17

No results posted yet for this study

Summary

CHF6297 is a potent and selective inhibitor of human MAP kinase p38 being developed as an anti-inflammatory agent for the treatment of inflammatory airways diseases. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of CHF6297 as dry powder formulation in healthy subjects and in COPD patients. This study is the first administration in humans.

The study will comprise four parts:

Part 1 will consist of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6297.

Part 2 will consist of four cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6297.

Part 3 will consist of one cohort of COPD patients to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a repeat dose of CHF6297

Part 4 will consist of one cohort of healthy subjects to assess the anti-inflammatory effect of a repeat dose of CHF6297 after LPS challenge.

Conditions

Interventions

DRUG

CHF6297 (Part 1 - SAD)

Single doses of CHF6297 at each period (for up to 3 periods per subject)

DRUG

Placebo (Part 1 - SAD)

Single doses of placebo matching CHF6297 at each period (for up to 3 periods per subject)

DRUG

CHF6297 (Part 2 - MAD)

Twice daily doses of CHF6297 for 7 days

DRUG

Placebo (Part 2 - MAD)

Twice daily doses of placebo matching CHF6297 for 7 days

DRUG

CHF6297 (Part 3)

Twice daily doses of CHF6297 for 14 days

DRUG

Placebo (Part 3)

Twice daily doses of placebo matching CHF6297 for 14 days

DRUG

CHF6297 (Part 4)

Twice daily doses of CHF6297 for 7 days

DRUG

Placebo (Part 4)

Twice daily doses of placebo matching CHF6297 for 7 days

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Stuart Mair, MD · Quotient Clinical

  • Dave Singh, MD · Medicines Evaluation Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-22
Primary Completion
2019-03-31
Completion
2019-03-31

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 NCT02815488 on ClinicalTrials.gov