A Single Dose Study of GBR 900 in Healthy Volunteers.
This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
37
Covance Clinical Research Unit Ltd
Leeds, Yorkshire, United Kingdom
Drug related adverse events (AEs) or any serious AEs
All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.
Time frame: 71 days
Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers
Time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers
Time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers
Time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Immunogenicity of GBR 900
Time frame: Pre-dose and at day 29, day 43, and day 71
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