Clinical Trial

SAD and MAD Study of AKB-9090 in Healthy Adult Participants

Recruiting Phase 1
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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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-14
Trial Details
NCT Number NCT07429006
Lead Sponsor Akebia Therapeutics
Collaborators: Emerald Clinical Trials
Conditions Healthy Volunteers
Enrollment 70 participants
Start Date 2026-03-16
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-13