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Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects

A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF 6523 After Single or Multiple Ascending Doses in Healthy Subjects, Followed by a Placebo Controlled Repeated Dose 2-way Crossover in COPD Subjects

NCT04032535•Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

Summary

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF6523 DPI in healthy male subjects first and then in COPD subjects after single or repeated dosesof CHF6523. As an exploratory assessment, the anti-inflammatory effect of CHF6523 in COPDsubjects will be evaluated.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject's written informed consent obtained prior to any study-related procedures;
•2. Male and female aged ≥40 years;
•3. A female is eligible to enter the study if she is of non-childbearing potential i.e.
•physiologically incapable of becoming pregnant (e.g. postmenopausal women defined as being amenorrheic for ≥12 consecutive months without an alternative medical cause. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels, according to local laboratory ranges) or women permanently sterilized (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy or non-fertile partner). Women physiologically capable of becoming pregnant \[i.e. women of childbearing potential (WOCBP)\] are eligible to enter the study if they have negative pregnancy test at screening and are fulfilling one of the following criteria:
•1. WOCBP with fertile male partners;
•2. WOCBP with non-fertile male partners;
•4. Male fulfilling one of the following criteria:
•1. Male with non-pregnant WOCBP partners;
•2. Male with pregnant WOCBP partner;
•5. Subject with an established diagnosis of COPD (according to GOLD guidelines, update 2019 \[7\]) at least 12 months prior to the screening visit;
+10 more criteria

Exclusion Criteria

•1. Pregnant or lactating female subject;
•2. Subject with a current diagnosis of asthma;
•3. Subject who have received or are planned to receive any type of vaccination within 3 weeks of their first dose of investigational product;
•4. Subject with a COPD exacerbation \[i.e. resulting in the use of systemic (oral/IV/IM) corticosteroids and/or antibiotics or visit to an emergency department or hospitalisation\] or a lower respiratory tract infection within 6 weeks prior to screening visit or between screening and randomisation;
•5. Subject on any maintenance therapy other than LABA/LAMA fixed combination within 2 months prior to screening visit;
•6. Subject receiving treatment with one or more drugs, and related time windows, listed in the prohibited medication section (see section 5.2.2);
•7. Subject requiring long-term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
•8. Subject participating to a pulmonary rehabilitation programme or completing such a programme within the last 6 weeks prior to screening visit;
•9. Subject with known respiratory disorders other than COPD that in investigator's opinion would affect efficacy and safety evaluation or place the subject at risk.
•This can include but is not limited to known -1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease;
+9 more criteria

Locations (1)

Richmond Pharmacology

London, United Kingdom

Key Dates

Start Date

July 24, 2019

Primary Completion Date

December 5, 2022

Completion Date

December 5, 2022

Last Updated

February 13, 2025

Enrollment

136

ACTUAL participants

Conditions

COPD

Interventions

CHF6523

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Effect of Telenursing on Oral Health

NCT07462221

COPD

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RECRUITINGNA

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

NCT07351929

COPD Exacerbation

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

Effect of Telenursing on Oral Health

Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

Probiotics in Pulmonaty Rehabilitation for COPD

Effects of Eccentric Exercise Training in Patients With COPD

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3