A study to evaluate the safety of a single dose of increasing amounts of PF0713 given via a vein to healthy adult male volunteers
A Phase 1, Open Label, Single-Center, Dose-Escalation, Cohort Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous (IV) Injection of PF0713 in Healthy Subjects
PharmacoFore, Inc.
39 participants
Dec 4, 2008
Interventional
Conditions
Summary
The purpose of this study is to test the safety and the effect on the body of a drug called PF0713. PF0713 is being developed for commencement and maintenance of anaesthesia and sedation. The hypothesis is that PF0713 will produce anaesthetic effects and be well tolerated.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
A single dose of PF0713 will be administered intravenously to each volunteer. The initial dose will be 0.0156 mg/kg. Doses will be increased by multiples of two. The maximum dose will be determined based upon observed responses (e.g., anesthesia for more than 10 minutes).
Locations(1)
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ACTRN12608000602325