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

Recruiting Phase 1 Interventional Study
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Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Akebia Therapeutics · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Healthy adult participants with no clinically significant findings, as judged by the investigator, based on physical examination, 12-lead ECG, alcohol breath test, and clinical laboratory tests (including serum chemistry, hematology, coagulation, urine drug screen, and uri…
Contacts

Dr. Leanne Barnett

+64 9 373 3474

propeller.auckland@nzcr.co.nz

CONTACT