A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03056326
• Date of registration: 03/02/2017
• Prospective Registration: No
• Primary sponsor: Chiesi Farmaceutici S.p.A.
• Public title: A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects CHF6333 FIH
• Scientific title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects
• Date of first enrolment: November 2016
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03056326
• Study type: Interventional
• Study design: Allocation: Randomized. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Frédéric Vanhoutte
• Affiliation: SGS Life Sciences

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male subjects aged 18-55 years

- BMI between 18-30 kg/m2

- Non smokers

- Lung function above 80% of predicted normal value

- Healthy subjects based on medical evaluation including medical history, physical
examination, laboratory tests and cardiac testing

Exclusion Criteria:

- Any clinically relevant abnormalities and/or uncontrolled diseases

- Abnormal laboratory values

- Recent respiratory tract infection

- Hypersensitivity to the drug or excipients

- Positive serology results

- Positive cotinine, alcohol, drug of abuse tests

- Unsuitable veins for repeated venepuncture



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Non-Cystic Fibrosis Bronchiectasis

Intervention(s)

Drug: CHF6333 (Part 1 - SAD)

Drug: Placebo (Part 2 - MAD)

Drug: CHF6333 (Part 2 - MAD)

Drug: Placebo (Part 1 - SAD)

Primary Outcome(s)

Adverse events [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15]

Change in Vital signs [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15]

Clinical chemistry and haematology [Time Frame: Part 1 Day 1-5, Part 2 Day 1-15]

QRS interval [Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15]

FEV1 [Time Frame: Part 1 Day 1-2, Part 2 Day 1-14-15]

Heart Rate [Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15]

Holter recording abnormalities [Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15]

PR interval [Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15]

Urinalysis [Time Frame: Part 1 Day 1-5, Part 2 Day 1-15]

QTcF interval [Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15]

Secondary Outcome(s)

Volume of distribution (Vz/F) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Clearance (CL/F) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Renal clearance (CLr) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

fraction excreted (fe) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Peak plasma concentration (Cmax) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Area under the plasma concentration [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Elimination half-life (t1/2) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Time to reach the maximum plasma concentration (tmax) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Urinary excretion (Ae) [Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15]

Secondary ID(s)

2015-005552-94

CCD-06333AA1-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors