A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of RV6153
NCT02517359 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55
Last updated 2016-03-04
Summary
RV6153 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD).
The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of RV6153
Conditions
- Asthma
- Healthy Volunteers
Interventions
- DRUG
-
RV6153 single dose
Safety and tolerability of single doses
- DRUG
-
RV6153 matching placebo single dose
Safety and tolerability of single doses
- DRUG
-
RV6153 14 day repeat dose
Safety and tolerability of repeat doses
- DRUG
-
RV6153 matching placebo 14 day repeat dose
Safety and tolerability of repeat doses
- DRUG
-
RV6153 28 day repeat dose
Safety and tolerability of repeat doses
- DRUG
-
RV6153 matching placebo 28 day repeat dose
Safety and tolerability of repeat doses
Sponsors & Collaborators
-
Respivert Ltd
lead INDUSTRY
Principal Investigators
-
Christopher O'Brien, MD, PhD, FCCP · Sponsor GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2015-07-31
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- United Kingdom
Study Locations
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