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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

NCT06746064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-02-12

No results posted yet for this study

Summary

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). The study will also evaluate the PK profile of study drug in plasma and urine after single and repeated administrations of CHF10073.

In addition, this study will also investigate the metabolites profile of CHF10073 in plasma, urine and faeces (Part 2 of the study) and the PK profile of CHF10073 in the lungs after bronchoalveolar lavage (BAL) (Part 3 of the study).

In addition, the effect of multiple doses of itraconazole on the pharmacokinetic profile of CHF10073 will be investigated (Part 4 of the study).

Conditions

Interventions

DRUG

CHF10073 (Part 1 - SAD)

Single doses of CHF10073 for each cohort

DRUG

Placebo (Part 1 - SAD)

Single doses of placebo matching CHF10073 for each cohort

DRUG

CHF10073 (Part 2 - MAD)

Multiple doses of CHF10073 for each cohort

DRUG

CHF10073 (Part 3)

Single dose of CHF10073

DRUG

Placebo (Part 2 - MAD)

Multiple doses of placebo matching CHF10073 for each cohort

DRUG

itraconazole (Part 4)

Multiple dose of itraconazole in treatment period 2

DRUG

CHF10073 (Part 4)

Single dose of CHF10073 in Treatment Period 1 and 2

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jelle Klein, MD · SGS Belgium

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-13
Primary Completion
2026-02-04
Completion
2026-02-04

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06746064 on ClinicalTrials.gov