Completed
A Placebo-controlled Double-blind Single and Repeated Ascending Dose Study to Investigate the Safety and Tolerability of Inhaled CHF 6001 in Healthy Volunteers
What is being tested
CHF 6001 SD or placebo
+ CHF 6001 MD or placebo
Drug
Who is being recruted
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
From 18 to 55 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: July 2011
Summary
Principal SponsorChiesi Farmaceutici S.p.A.
Last updated: July 31, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2011
Actual date on which the first participant was enrolled.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.
Principal SponsorChiesi Farmaceutici S.p.A.
Last updated: July 31, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
74 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive
Criteria
7 inclusion criteria required to participate
A reliable method of contraception for the subjects and their partner
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
Male healthy volunteers aged 18-55 years
Show More Criteria
9 exclusion criteria prevent from participating
Blood donation or blood loss less than 8 weeks before inhalation of the study medication
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
Heavy caffeine drinker ( > 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSingle administration of CHF 6001 dose levels 1 to 7 or placebo
Group II
ExperimentalMultiple administration of CHF 6001 dose levels 1 to 5 or placebo
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center