A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001
NCT02386761 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2020-07-31
Summary
A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.
Conditions
Interventions
- DRUG
-
Single Ascending Dose (SAD)
- DRUG
-
Multiple Ascending Dose (MAD)
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Stuart Mair, MD · Quotient Clinical
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2015-05-31
- Completion
- 2015-05-31
Countries
- United Kingdom
Study Locations
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