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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02386761

Acronym

CHF6001Ext

Enrollment

Registered

2015-03-12

Start date

2014-11-30

Completion date

2015-05-31

Last updated

2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Brief summary

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.

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.

Interventions

DRUGSingle Ascending Dose (SAD)

DRUGMultiple Ascending Dose (MAD)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026