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AKB-9090

Phase 1

Healthy Volunteers | Small molecule | Other |Akebia Therapeutics, Inc.|Last Updated: Apr 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment70
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07429006SAD and MAD Study of AKB-9090 in Healthy Adult ParticipantsPHASE1 RECRUITING 70 — — Mar 16, 2026Dec 1, 2026Apr 13, 20261 New Zealand
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Study Endpoints
Primary Endpoints
Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Physical Examinations
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Vital Signs
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Chemistry parameters
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Hematology Parameters
from first dose to Day 7
Number of Participants with Clinically Significant Changes in Lipid Parameters
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Coagulation Parameters
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Urinalysis Parameters
From First Dose to Day 7
Secondary Endpoints
Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090
At Day 1
Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090
At Day 1
Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090
At Day 1
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AKB-9090EXPERIMENTALParticipants will receive a single intravenous (IV) dose of AKB-9090 at 5 escalating dose levels in the SAD stage and at 3 dose levels in the MAD stage.
PlaceboPLACEBO_COMPARATORSingle IV dose of matching Placebo.
Interventions
NameTypeDescription
AKB-9090DRUGAKB-9090 will be administered intravenously
PlaceboOTHERMatching Placebo administered intravenously
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:New Zealand
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07429006Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07429006studyFirstPostDate: changed