drugset / Trial / NCT07429006

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

NCT07429006 ↗

RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2026-03-16
Primary completion
2026-10
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AKB-9090 Unknown — Intravenous

Indications

No indication recorded.