clinical trial · NCT07429006
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
Healthy VolunteersAKB-9090Placebo
brief summary
This is a first-in-human (FIH study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic effects of AKB-9090 in healthy adult participants. The study consists of two stages: Stage 1, a single ascending dose (SAD) phase with five dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with three dose cohorts. Approximately 40 participants in SAD and 30 in MAD are planned to be enrolled.
started
Mar 16, 2026
primary completion
Oct 1, 2026
completion
Dec 1, 2026
last updated
Apr 13, 2026
official title
A Randomized, Double-Blind, Placebo-Controlled, Single (SAD) and Multiple Ascending-Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AKB-9090 Administered Intravenously to Healthy Adult Participants
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