A phase I study to evaluate an investigational medicinal product for the treatment of asthma, in healthy adult participants.

Trial details

Who runs it

Chiesi Farmaceutici S.p.A.

Trial code

EU 2023-504326-19-00

Record updated

2024. január 15.

Original description

To evaluate the lung availability and total systemic exposure of beclometasone dipropionate (BDP) and beclometasone 17-monoproprionate (B17MP) (B17MP; active metabolite of BDP) after administration of CHF 718 200 µg pMDI HFA-152a with the Volumatic® spacer, in comparison with CHF 718 200 µg pMDI HFA-134a with the Volumatic® spacer.Read full original descriptionShow less

A single dose, randomized, double-blind, 2-way crossover clinical pharmacology study, to evaluate the lung availability and the systemic exposure of beclometasone dipropionate and beclometasone 17-monoproprionate (active metabolite of beclometasone dipropionate), after inhalation of CHF 718 pMDI HFA-152a 200 μg 4-inhalations in comparison with CHF 718 pMDI HFA-134a 200 μg 4-inhalations, using Volumatic® spacer in healthy volunteers.

To evaluate the lung availability and total systemic exposure of beclometasone dipropionate (BDP) and beclometasone 17-monoproprionate (B17MP) (B17MP; active metabolite of BDP) after administration of CHF 718 200 µg pMDI HFA-152a with the Volumatic® spacer, in comparison with CHF 718 200 µg pMDI HFA-134a with the Volumatic® spacer.

Inclusion: Subject’s written informed consent obtained prior to any study related procedure; Female subjects fulfilling one of the following criteria: a)Women of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e., postmenopausal or permanently sterile, as per definitions given in APPENDIX 2 and in Section 1.1 of the Clinical Trials Facilitation and Coordination Group guidance. Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per Investigator’s request, postmenopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges). b) Women of childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or; ii. WOCBP with non-fertile male partners (contraception is not required in this case); Healthy male and female subjects aged 18 to 55 years inclusive; Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly; subjects will not be included if the training is not completed successfully; Body mass index (BMI) within the range of 19.0 to 30.0 kg/m2 (extremes inclusive) and body weight ≥ 50.0 kg; Non-smokers, or ex-smokers who smoked < 5 pack-years [pack-years = (number of packs per day) x (number of years)] and stopped smoking ≥ 1 year prior to screening; Good physical and mental status, determined on the basis of medical history and a general clinical examination, at screening and before randomisation; Vital signs within normal limits at screening: diastolic blood pressure (DBP) 40-90 mmHg, systolic blood pressure (SBP) 90-140 mmHg extremes included (two measures performed after at least 5 minutes of rest; the mean value must be within the defined range); body temperature < 37.5°C; Twelve-lead digitised electrocardiogram (12-lead ECG) intriplicate considered as normal (40 bpm ≤ heart rate [HR] ≤ 110 bpm, 120 ms ≤ PR interval [PR] ≤ 220 ms, QRS interval [QRS] ≤ 120 ms, QT interval corrected using Fridericia’s formula [QTcF] ≤ 450 ms for males and QTcF ≤ 470 ms for females) at screening visit (the mean value must be within the defined range); Lung function measurements within normal limits at screening (normal values: forced expiratory volume in the 1st second [FEV1]/forced vital capacity [FVC] > 0.70 and FEV1 > 80% predicted).

Exclusion: Participation in another clinical study with an investigational drug in the 30 days or five half-lives of that investigational drug (whichever is longer) preceding the administration of the study treatment; a longer and more appropriate time could be considered by the Investigator based on the elimination half-life (t1/2) and/or long-term toxicity of the previous investigational drug; Positive urine test for cotinine at screening, or prior to randomisation; Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks, or associated complications/symptoms from this disease, which have not resolved within 2 weeks prior to screening; COVID-19 positive subjects on D-1 of treatment period 1 with no official recovery certificate available; Blood donation or blood loss (≥ 450 mL), less than 2 months prior to screening or prior to randomisation; Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders that may interfere with successful completion of this protocol according to the Investigator’s judgment; Subjects with a history of significant respiratory diseases (i.e., history of asthma including childhood asthma); Positive serology test for human immunodeficiency virus (HIV) 1 or HIV2 at screening; Positive results from the hepatitis serology which indicates acute or chronic hepatitis B or hepatitis C at screening (e.g., positive hepatitis B surface antigen [HBsAg], hepatitis C virus [HCV] antibody with detectable HCV ribonucleic acid [RNA]); Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation, or which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator’s judgment; Abnormal haemoglobin (Hb) level, defined as < 11.0 g/dL in females and < 12.9 g/dL in males, in agreement with the local laboratory normal ranges.

EU CTIS 2023-504326-19-00