NCT07429006

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Akebia Therapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AKB-9090	AKB-9090 will be administered intravenously
OTHER	Placebo	Matching Placebo administered intravenously

Timeline

• Start date: 2026-03-16
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-02-24
• Last updated: 2026-04-13

Locations

1 site across 1 country: New Zealand