drugset / Trial / NCT07429006
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AKB-9090 | Unknown | — | Intravenous |
Indications
No indication recorded.