A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001 (CHF6001Ext)

July 30, 2020 updated by: Chiesi Farmaceutici S.p.A.

A Phase 1, Randomised Double-blind, Placebo-controlled STUDY of Single and Repeated Ascending doseS in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6001

A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess the safety and tolerability of single and repeated ascending doses of CHF 6001 in healthy volunteers and to investigate the pharmacokinetic (PK) profile of CHF 6001 and its metabolites CHF 5956 and CHF 6095.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • UK
      • Nottingham, UK, United Kingdom, NG116JS
        • Quotient Clinical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Main Inclusion

  • Subject's written informed consent obtained prior to any study-related procedure
  • Male and female Caucasian healthy volunteers aged 18-55 years inclusive
  • Vital signs:Subjects aged 18-45: Diastolic BP 40-90, Systolic BP 90-140 Subjects aged 45-55: Diastolic BP 40-90, Systolic BP 90-150 (as mean of three measures performed after at least 5 minutes of resting); checked at screening visit and Day -1
  • 12-lead digitised Electrocardiogram (12-lead ECG) considered as normal (40≤Heart rate≤110bpm,120 ms ≤ PR ≤ 210 ms, QRS ≤ 120 ms, QTcF ≤ 450 ms for males and ≤ 470ms for females) checked at screening visit and Day -1
  • Lung function measurements within normal limits: FEV1 > 80% of predicted normal value (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Values (1,2) ) and FEV1/FVC ratio > 0.70

Main Exclusion:

  • Pregnant or lactating women
  • Clinically significant cardiac abnormalities
  • Any clinically relevant abnormal laboratory values

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Single Ascending Dose (SAD)
  • Dose 1 (SAD1): 6 inhalations of CHF 6001 400 µg giving a total dose of 2400 µg
  • Dose 2 (SAD2): 10 inhalations of CHF 6001 400 µg giving a total dose of 4000 µg
  • Dose 3 (SAD3): 12 inhalations of CHF 6001 400 µg giving a total dose of 4800 µg Placebo (P): the number of placebo inhalations will match that of the active CHF 6001 pertaining to the same dose period.

In case the actual doses are modified, the number of inhalations will be adapted accordingly.
Drug: Single Ascending Dose (SAD)
Other Names:
  • CHF6001
EXPERIMENTAL: Multiple Ascending Dose (MAD)
  • Dose 1 (MAD1): Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo
  • Dose 2 (MAD2): Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo
  • Dose 3 (MAD3): Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo

Duration 14 days b.i.d.
Drug: Multiple Ascending Dose (MAD)
Other Names:
  • CHF6001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 0-14 days
0-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

January 22, 2015

First Submitted That Met QC Criteria

March 11, 2015

First Posted (ESTIMATE)

March 12, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 30, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-06001AA1-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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