Actively Recruiting
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
Led by Akebia Therapeutics · Updated on 2026-04-13
70
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
Sponsors
A
Akebia Therapeutics
Lead Sponsor
E
Emerald Clinical Trials
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults with no significant findings on physical exam, ECG, breath test, or lab tests
- Body mass index between 18.5 and 32.0 kg/m2 at screening
- Able and willing to give informed consent and follow all study rules including confinement and visits
You will not qualify if you...
- Any significant metabolic, liver, kidney, blood, lung, heart, digestive, muscle, skin, urinary, eye, ear/nose/throat, psychiatric, or neurological disorder
- History of active or recurrent cancer within 2 years or current cancer treatment, except certain treated skin or in situ cancers
- Abnormal ECG findings such as severe slow heart rate or prolonged QT interval
- Elevated liver enzymes or creatinine above 1.25 times normal at screening
- Evidence of hepatitis B or C infection
- Use of nicotine, caffeine, or alcohol during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Investigator Site #1
Auckland, New Zealand
Actively Recruiting
Research Team
D
Dr. Leanne Barnett
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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