Safety, Tolerability and Pharmacokinetic Study of Biota-CS-8958
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
This study will look at the safety, tolerability and what the body does to CS-8958 given to
40 healthy volunteers 18-55 years old. CS-8958 is a dry-powder investigational drug that is
breathed into the lungs through an inhaler device. The researchers will collect information
about any problems that volunteers have while taking the drug and about changes in blood
pressure and how the heart is working. Volunteers will have breathing tests, physical
examinations, and blood samples collected for laboratory tests. The researchers will also
look at how much of the medication travels throughout the body versus how much stays only in
the lungs. Doses of the medication will be tested at one level and then at higher and higher
levels after a safety committee reviews the safety and tolerability information on volunteers
prior to the next higher dose being given. Each volunteer will participate for up to 6 weeks
from initial screening to the follow up visit and spend 7 days in the clinic.
Phase:
Phase 1
Details
Lead Sponsor:
Biota Scientific Management Pty Ltd
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)