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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-22

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF6297 Active

Group Type EXPERIMENTAL

CHF6297 (Part 1 - SAD)

Intervention Type DRUG

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

CHF6297 (Part 2 - MAD)

Intervention Type DRUG

Twice daily doses of CHF6297 for 7 days

CHF6297 (Part 3)

Intervention Type DRUG

Twice daily doses of CHF6297 for 14 days

CHF6297 (Part 4)

Intervention Type DRUG

Twice daily doses of CHF6297 for 7 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (Part 1 - SAD)

Intervention Type DRUG

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

Placebo (Part 2 - MAD)

Intervention Type DRUG

Twice daily doses of placebo matching CHF6297 for 7 days

Placebo (Part 3)

Intervention Type DRUG

Twice daily doses of placebo matching CHF6297 for 14 days

Placebo (Part 4)

Intervention Type DRUG

Twice daily doses of placebo matching CHF6297 for 7 days

Interventions

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CHF6297 (Part 1 - SAD)

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

Intervention Type DRUG

Placebo (Part 1 - SAD)

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

Intervention Type DRUG

CHF6297 (Part 2 - MAD)

Twice daily doses of CHF6297 for 7 days

Intervention Type DRUG

Placebo (Part 2 - MAD)

Twice daily doses of placebo matching CHF6297 for 7 days

Intervention Type DRUG

CHF6297 (Part 3)

Twice daily doses of CHF6297 for 14 days

Intervention Type DRUG

Placebo (Part 3)

Twice daily doses of placebo matching CHF6297 for 14 days

Intervention Type DRUG

CHF6297 (Part 4)

Twice daily doses of CHF6297 for 7 days

Intervention Type DRUG

Placebo (Part 4)

Twice daily doses of placebo matching CHF6297 for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Part 1, Part 2, Part 4 (Healthy subjects):

* Male subjects aged 18-55 years;
* Non smokers
* Lung function above 80% of predicted normal value
* Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
* ability to produce an adequate induced sputum sample (study part 4 only)

Part 3 (COPD patients):

* Males and females aged 40-75 years
* Current or past smokers
* stable patients with a post-bronchodilator FEV1 between 40 and 80% of predicted normal value and FEV1/FVC ratio \<0.7
* Ability to produce a spontaneous and an adequate induced sputum sample

Exclusion Criteria

Parts 1,2, 4 (Healthy subjects):

* Any clinically relevant abnormalities and/or uncontrolled diseases
* Abnormal laboratory values
* Recent respiratory tract infection
* Hypersensitivity to the drug or excipients
* Positive serology results
* Positive cotinine, alcohol, drug of abuse tests

Part 3 (COPD patients):

* Females of childbearing potential
* History of asthma
* Unstable concomitant diseases
* Abnormal relevant Holter ECG parameters
* Recent acute exacerbations of COPD or respiratory tract infection
* Hypersensitivity to the drug or excipients
* Positive serology results

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes