Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GB-0669 in Healthy Adult Participants
Status:
COMPLETED
Trial end date:
2024-11-22
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to test the safety and tolerability of a single ascending dose (SAD) of GB-0669 administered intravenously in adults. The goal of this study is also to measure the blood levels of GB-0669 in the body.
Study participants will be assigned to receive the study drug or placebo (the placebo is called saline; it is a liquid like salt water and made to look like the study drug but contains no active ingredient).
The study is blinded, which means you and the study doctor will not know whether you are getting the study drug or placebo.
Study participants will be assigned to one of 5 cohorts (study groups). Each cohort will have a single ascending dose (SAD). The first two SAD cohorts will have 3 study participants receiving GB-0669 and 3 study participants receiving placebo. The last three SAD cohorts will have 10 study participants receiving GB-0669 and 3 study participants receiving placebo. The SAD cohort dose levels will be as follows: 100 mg, 300 mg, 600 mg, 1200 mg, 2400 mg.