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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

ConditionBronchiectasis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChiesi Farmaceutici S.p.A.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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

Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders that may interfere with successful completion of this protocol, according to the investigator's judgment;

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 results of the study, according to the investigator's judgment;

History of respiratory diseases;

Trial design

Design model

Crossover

Treatments tested in this trial

  • CHF6333

    Drug

    CHF6333 Part I SAD; CHF6333 Part II MD.

  • CHF6333 Placebo

    Drug

    Placebo Part I SAD; Placebo Part II MD.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Experimental: CHF6333Experimental treatment 1 intervention
Group B: Placebo comparator: CHF6333 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
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
2

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

Arterial blood pressure (SBP and DBP)

Time frame
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
3

heart rate (HR)

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).

Time frame
Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose
4

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

Part I HVs only and Part II

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

Secondary outcomes

1

Pharmacokinetic variables in plasma in HVs only (Part I), in terms of Area Under the Curve

Area under the plasma concentration versus time curve (AUC) from Time 0 to 30 minutes post-dose (AUC0-30min), AUC from Time 0 to 12 hours post-dose (AUC0-12h), AUC from Time 0 to 24 hours post-dose (AUC0-24h), AUC from Time 0 to 96 hours post-dose (AUC0-96h), AUC from Time 0 to time of last quantifiable concentration (AUC0-t), AUC from Time 0 to infinity (AUC0-∞)

Time frame
Day 1: from pre-dose until 96 hours post-dose
2

Pharmacokinetic variables in plasma in HVs only (Part I): Maximum concentration (Cmax)

Time frame
Day1: from pre-dose until 96 hours post-dose
3

Pharmacokinetic variables in plasma in HVs only (Part I): Time to maximum concentration (tmax)

Time frame
Day1: from pre-dose until 96 hours post-dose
4

Pharmacokinetic variables in plasma in HVs only (Part I): Terminal half-life (t½)

Time frame
Day 1: from pre-dose until 96 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiesi Farmaceutici S.p.A.

Lead sponsor

Source ClinicalTrials.gov
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