RecruitingPhase 1/2

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

United Kingdom45 participantsStarted 2023-11-29

Plain-language summary

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 with BE - Part II

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed and dated informed consent obtained prior to any study-related procedure;
✓. Healthy male or female subject ≥18 and ≤60 years of age at screening;
✓. Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
✓. Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
✓. Non-smokers or ex-smokers who smoked \<5 pack-years and stopped smoking \>1 year prior to screening;
✓. Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation;
✓. Vital signs within normal limits at screening and prior to randomisation: diastolic blood pressure (DBP) ≥40 and ≤89 mmHg, and systolic blood pressure (SBP) ≥90 and ≤139 mmHg; body temperature \<37.5°C;
✓. Triplicate 12-lead electrocardiogram (ECG) considered as normal (40 ≤ heart rate ≤110 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤120 ms, Fridericia corrected QT interval \[QTcF\] ≤450 ms for males and QTcF ≤470 ms for females) at screening and prior to randomisation;

Exclusion criteria

✕. Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior to randomisation;
✕

What they're measuring

Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of AEs

Timeframe: Through study completion. Part I: an average of 12 weeks and 8 weeks respectively for HVs and BE subjects. Part II: an avarage of 26 weeks

Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of vital signs

Timeframe: Part I:screening, day(D)-1, D1(from pre-dose until 96hrs post-dose HV, 6hrs post-dose BE), 14 to 21D post-dose.Part II:screening, D-1, D1 and 27(from pre-dose until 6hrs post-dose), D28(from pre-dose until 2hrs post-dose), 14 to 21D after last dose

heart rate (HR)

Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose

Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of 12-Lead ECG parameters from Holter: PR interval

Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose

Trial details

NCT IDNCT06166056

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Chiesi Clinical Trial info

+39 0521 2791 Clinicaltrials_info@chiesi.com

View on ClinicalTrials.gov More Bronchiectasis trials

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed and dated informed consent obtained prior to any study-related procedure;
✓. Healthy male or female subject ≥18 and ≤60 years of age at screening;
✓. Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
✓. Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
✓. Non-smokers or ex-smokers who smoked \<5 pack-years and stopped smoking \>1 year prior to screening;
✓. Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation;
✓. Vital signs within normal limits at screening and prior to randomisation: diastolic blood pressure (DBP) ≥40 and ≤89 mmHg, and systolic blood pressure (SBP) ≥90 and ≤139 mmHg; body temperature \<37.5°C;
✓. Triplicate 12-lead electrocardiogram (ECG) considered as normal (40 ≤ heart rate ≤110 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤120 ms, Fridericia corrected QT interval \[QTcF\] ≤450 ms for males and QTcF ≤470 ms for females) at screening and prior to randomisation;

Exclusion criteria

✕. Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior to randomisation;
✕

What they're measuring

Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of AEs

Timeframe: Through study completion. Part I: an average of 12 weeks and 8 weeks respectively for HVs and BE subjects. Part II: an avarage of 26 weeks

Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of vital signs

heart rate (HR)

Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose