Status:
COMPLETED
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Respiratory Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV)...
Eligibility Criteria
Inclusion
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Exclusion
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Key Trial Info
Start Date :
February 22 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2013
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01818024
Start Date
February 22 2013
End Date
October 25 2013
Last Update
May 15 2017
Active Locations (1)
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1
GSK Investigational Site
Harrow, Middlesex, United Kingdom, HA13UJ