A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers

Chiesi Farmaceutici S.p.A.1 site in 1 country74 target enrollmentStarted: July 2011Last updated: July 31, 2020

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsCHF 6001 SD or placebo CHF 6001 MD or placebo

DrugsCHF 6001 SD or placebo CHF 6001 MD or placebo

Overview

Phase: Phase 1
Status: Completed
Sponsor: Chiesi Farmaceutici S.p.A.
Enrollment: 74
Locations: 1
Primary Endpoint: Body weight

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

This study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001 after single and multiple doses in healthy volunteers.

Detailed Description

The study will be conducted in a single centre and will consist of a single dose part and a multiple dose part.

Seven single doses of CHF 6001 will be administered according to an escalation, alternate cross over scheme. Five multiple doses of CHF 6001 will be administered for 7 days according to a sequential escalation scheme.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 55 Years (Adult)
Sex: Male
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Subject's written informed consent obtained prior to any study-related procedure
•Male healthy volunteers aged 18-55 years;
•Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
•Body Mass Index (BMI) between 18.0 and 28.0 kg/m2;
•Non- or ex-smokers who smoked \< 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking \> 1 year;
•Results of laboratory tests within the normal ranges. Minor deviations are acceptable provided that they are not judged clinically significant by the investigator.
•A reliable method of contraception for the subjects and their partner.

Exclusion Criteria

•Blood donation or blood loss less than 8 weeks before inhalation of the study medication;
•Positive HIV1 or HIV2 serology;
•Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
•History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
•Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
•Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
•Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
•Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre.
•Heavy caffeine drinker (\> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).

Arms & Interventions

CHF 6001 SD or placebo

Experimental

Single administration of CHF 6001 dose levels 1 to 7 or placebo

Intervention: CHF 6001 SD or placebo (Drug)

CHF 6001 MD or placebo

Experimental

Multiple administration of CHF 6001 dose levels 1 to 5 or placebo

Intervention: CHF 6001 MD or placebo (Drug)