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A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects (CHF6333 FIH)

Primary Purpose

Non-Cystic Fibrosis Bronchiectasis, Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

CHF6333 (Part 1 - SAD)

Placebo (Part 1 - SAD)

CHF6333 (Part 2 - MAD)

Placebo (Part 2 - MAD)

About this trial

This is an interventional treatment trial for Non-Cystic Fibrosis Bronchiectasis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Male subjects aged 18-55 years
BMI between 18-30 kg/m2
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

Exclusion Criteria:

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
Unsuitable veins for repeated venepuncture

Sites / Locations

SGS Life Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CHF6333 Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Adverse events

Treatment-related Adverse events

Change in Vital signs

Blood pressure

Heart Rate

Change in Heart Rate (from ECG)

QTcF interval

Change in QTcF interval (from ECG)

PR interval

Change in PR interval (from ECG)

QRS interval

Change in QRS interval (from ECG)

Holter recording abnormalities

24h-holter ECG recording

FEV1

Change in FEV1 (Forced exhalation volume in the first second)

Clinical chemistry and haematology

change in Clinical chemistry and haematology parameters

Urinalysis

Change in urinalysis parameters

Secondary Outcome Measures

Area under the plasma concentration

Peak plasma concentration (Cmax)

maximum plasma concentration of CHF6333

Time to reach the maximum plasma concentration (tmax)

Elimination half-life (t1/2)

Clearance (CL/F)

Absolute plasma clearance

Volume of distribution (Vz/F)

plasma volume of distribution

Urinary excretion (Ae)

Amount of CHF6333 excreted in urine

fraction excreted (fe)

Percentage of drug excreted in urine

Renal clearance (CLr)

Full Information

NCT ID

NCT03056326

First Posted

February 3, 2017

Last Updated

November 6, 2017

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT03056326

Brief Title

A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects

Acronym

CHF6333 FIH

Official Title

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

July 2017 (Actual)

Study Completion Date

July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects. The study will comprise two parts: Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333. Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Cystic Fibrosis Bronchiectasis, Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Model Description

Part 1: alternating cross-over design Part 2: parallel design

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHF6333 Active

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

CHF6333 (Part 1 - SAD)

Intervention Description

Single doses of CHF6333 at each period

Intervention Type

Drug

Intervention Name(s)

Placebo (Part 1 - SAD)

Intervention Description

Single doses of placebo matching CHF6333 at each period

Intervention Type

Drug

Intervention Name(s)

CHF6333 (Part 2 - MAD)

Intervention Description

once daily multiple doses of CHF6333 for 14 days

Intervention Type

Drug

Intervention Name(s)

Placebo (Part 2 - MAD)

Intervention Description

once daily multiple doses of placebo matching CHF6333 for 14 days

Primary Outcome Measure Information:

Title

Adverse events

Description

Treatment-related Adverse events

Time Frame

Part 1 from Day 1 to 5, Part 2 from Day 1 to 15

Title

Change in Vital signs

Description

Blood pressure

Time Frame

Part 1 from Day 1 to 5, Part 2 from Day 1 to 15

Title

Heart Rate

Description

Change in Heart Rate (from ECG)

Time Frame

Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15

Title

QTcF interval

Description

Change in QTcF interval (from ECG)

Time Frame

Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15

Title

PR interval

Description

Change in PR interval (from ECG)

Time Frame

Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15

Title

QRS interval

Description

Change in QRS interval (from ECG)

Time Frame

Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15

Title

Holter recording abnormalities

Description

24h-holter ECG recording

Time Frame

Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15

Title

FEV1

Description

Change in FEV1 (Forced exhalation volume in the first second)

Time Frame

Part 1 Day 1-2, Part 2 Day 1-14-15

Title

Clinical chemistry and haematology

Description

change in Clinical chemistry and haematology parameters

Time Frame

Part 1 Day 1-5, Part 2 Day 1-15

Title

Urinalysis

Description

Change in urinalysis parameters

Time Frame

Part 1 Day 1-5, Part 2 Day 1-15

Secondary Outcome Measure Information:

Title

Area under the plasma concentration

Time Frame