Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
Asthma, Healthy Volunteers
Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma
This study evaluates the safety and tolerability of CHF10136 administered by inhalation in healthy adults and adults with asthma.
- Trial name
- NCT07851623
- Testing
- CHF10136
- Where
- 3 sites in United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
Evaluation of Safety, Side Effects and How the Drug CHF6467 Administered Via Intranasal Route is Absorbed, Modified and Removed in Healthy Subjects
A clinical trial to investigate the safety and tolerability of single and multiple intranasal (through the nose) dosing with the study drug CHF6467 in 68 healthy adult subjects.
- Trial name
- NCT07163182
- Testing
- CHF6467 Part 1 (SAD), CHF6467 Part 2 (MAD)
- Where
- Bulgaria
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
AssessmenT of smalL Airways involvemeNT In aSthma (ATLANTIS)
Multinational, multicentre, non-pharmacological intervention, cross-sectional and longitudinal study.
- Trial name
- ATLANTIS (NCT02123667)
- Where
- 26 sites in United States, Brazil and 6 more
- Volunteers
- 872 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Male Volunteers
A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a…
- Trial name
- NCT07744386
- Testing
- Dabigatran Etexilate, Rosuvastatin, CHF10196
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy Volunteers
A Study to Compare How CHF10196 (Florensocatib) is Absorbed Into the Blood When Given Alone and With a Drug That Reduces Stomach Acid in Healthy Male Participants
This Phase 1 study evaluates the effect of pantoprazole (a proton pump inhibitor) on the pharmacokinetics (PK) of CHF10196 (Florensocatib) in healthy male participants.
- Trial name
- NCT07683793
- Testing
- CHF10196, Pantoprazole
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Bronchiectasis
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis
The aim of this clinical trial is to assess the safety of: single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I repeated doses of the study drug CHF6333 in subjects…
- Trial name
- NCT06166056
- Testing
- CHF6333
- Where
- 9 sites in United Kingdom
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pulmonary Fibrosis
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 Exposure
The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study).
- Trial name
- NCT06746064
- Testing
- CHF10073 (Part 1 - SAD), CHF10073 (Part 2 - MAD), CHF10073 (Part 3)
- Where
- Belgium
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD)
Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study
The main goal of this pharmacokinetic study in healthy volunteers is to evaluate the potential effect of cyclosporine (probe inhibitor of P glycoprotein [P-gp] and breast cancer resistance protein [BCRP] transporters) on CHF6001…
- Trial name
- DDI2 (NCT06892756)
- Testing
- CHF6001 dry powder inhaler (DPI), Cyclosporine, CHF6001 DPI
- Where
- Bulgaria
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD
Investigate the Safety, Tolerability and Pharmacokinetics of CHF6523 in Healthy and in COPD Subjects
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.
- Trial name
- CHF6523 (NCT04032535)
- Testing
- CHF6523
- Where
- United Kingdom
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Mucociliary Clearance
Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance
The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC).
- Trial name
- NCT05875025
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®
The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized…
- Trial name
- NCT05898984
- Testing
- Test product (T):CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI, Reference product 1 (R1): CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI, Reference product 2 (R2): BDP HFA (QVAR REDIHALER®, BDP 80 μg)
- Where
- Belgium
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
A Thorough QT (TQT) Study of CHF5993 pMDI in Healthy Volunteers (HV)
The purpose of this study is to evaluate the potential for cardiac repolarization, according to electrocardiographic monitoring (including QT and QTc intervals), of two dose levels of CHF5993 pMDI (beclomethasone…
- Trial name
- NCT05830071
- Testing
- CHF5993, CHF5259, Moxifloxacin 400mg
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Effect of Erythromycin on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers
The objective of this study is to investigate the effect of the interaction of Erythromycin (CYP3A4/5 moderate inhibitor) on the pharmacokinetic of CHF6001 (CYP3A4/5 substrate) in Healthy Volunteers.
- Trial name
- NCT06395610
- Testing
- CHF6001 DPI, Erythromycin
- Where
- Bulgaria
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Clinical Study to Investigate the Pharmacokinetics, Safety and Tolerability Following Single Administration of CHF6001 in Subjects With Mild, Moderate and Severe Liver Impairment in Comparison With Matched Healthy Control Subjects
A clinical trial to investigate the pharmacokinetics, safety and tolerability of CHF6001 after single administrations in participants with mild, moderate and severe liver impairment with matched healthy adult volunteers
- Trial name
- NCT05373953
- Testing
- CHF6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease (COPD), COPD
Evaluation of the Absolute Bioavailability and Mass Balance of CHF6001 (Tanimilast) in Healthy Subjects
The objective of the study is to evaluate the bioavailability of CHF6001 after inhaled administration, to characterize the mass balance and route of elimination of CHF6001 along with its relevant metabolites, in healthy male…
- Trial name
- NCT04756960
- Testing
- CHF6001
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
PK of CHF6001 in Subjects With Mild, Moderate and Severe Renal Impairment vs. Healthy Volunteers
The purpose of the study is to obtain pharmacokinetics, safety and tolerability data after single administrations of CHF6001 in subjects with mild, moderate and severe renal impairment as well as healthy volunteers under the same…
- Trial name
- NCT05431426
- Testing
- CH6001
- Where
- Bulgaria
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease, Asthma
Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients
The purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in…
- Trial name
- STORM (NCT03795350)
- Testing
- Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide
- Where
- United Kingdom
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Pulmonary Disease, Chronic Obstructive, Asthma
Lung Deposition of the BDP/Formoterol Combination Administered Via the NEXT DPI in Healthy, Asthmatic and COPD Patients
The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone and Formoterol using a gamma-scintigraphic technique after inhalation of a single dose of 99mTc-radiolabelled…
- Trial name
- NCT01176747
- Testing
- BDP/formoterol NEXT DPI
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Healthy
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
- Trial name
- Gly1 (NCT01176851)
- Testing
- Glycopyrrolate
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD
Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).
- Trial name
- TRIPLE 1 (NCT01398111)
- Testing
- Glycopyrrolate + Formoterol, Glycopyrrolate, Formoterol
- Where
- Belgium
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.