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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AKB-9090; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr. Leanne Barnett; Phone Number: +64 9 373 3474; Email: propeller.auckland@nzcr.co.nz

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Recruiting
    • Investigator Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 urinalysis).
• Body mass index (BMI) greater than 18.5 and less than 32.0 kg/m^2 at screening.
• In the Investigator's opinion, willing and able to provide written informed consent and comply with the all protocol requirements, including required confinement, outpatient visits, and protocol-specified restrictions (including refraining from major lifestyle changes) from signature of the informed consent form (ICF) through the last study visit.

Key Exclusion Criteria:

• Clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatologic, urogenital, ophthalmologic, ear/nose/throat, psychiatric, or neurologic disorder.

• History of active or recurrent malignancy within 2 years before screening or during the screening period, or currently receiving treatment or suppressive therapy for cancer, except for:

  1. Treated basal cell carcinoma of the skin
  2. Curatively resected squamous cell carcinoma of the skin
  3. Treated colonic or cervical carcinoma in situ

• Abnormal ECG findings at screening, including:

  1. Severe bradycardia (heart rate <40 beats per minute) on any measurement
  2. Mean QT Interval Using Fridericia's Formula (QTcF) >450 msec for males or >470 msec for females
• Elevated laboratory values (>1.25 × upper limit of normal [ULN]) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine at the screening visit or at check-in.
• Evidence of acute or chronic hepatitis B (positive hepatitis B surface antigen) or hepatitis C infection (positive hepatitis C antibody and positive hepatitis C ribonucleic acid [RNA] test).
• Use of nicotine-containing products (including cigarettes, cigars, tobacco, gum, patches, vaping, and e-cigarettes), caffeine-containing foods or beverages, and alcohol-containing foods or beverages during study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AKB-9090; Participants 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.	Drug: AKB-9090; AKB-9090 will be administered intravenously
Placebo Comparator: Placebo; Single IV dose of matching Placebo.	Other: Placebo; Matching Placebo administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090	At Day 1
Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090	At Day 1
Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090	At Day 1
Stage 2 MAD Cohorts: Cmax of AKB-9090	At Day 1 and Day 7
Stage 2 MAD Cohorts: Tmax of AKB-9090	At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090	At Day 1
Stage 2 MAD Cohorts: CL of AKB-9090	At Day 1 and Day 7
Stage 2 MAD Cohorts: T1/2 of AKB-9090	At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090	At Day 7
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Erythropoietin (EPO)	Baseline (Day 1) and at 6, 12, 18, and 24 hours post-dose
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Red Blood Cell Count (RBC)	Baseline (Day 1) and At Day 2
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count	Baseline (Day 1) and At Day 2
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - EPO	Baseline (Day 1 and Day 7) and at 6, 12, 18, and 24 hours post-dose
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - RBC	Baseline (Day 1) and At Days 4 and 8
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count	Baseline (Day 1) and At Days 4 and 8

Collaborators and Investigators

• Sponsor: Akebia Therapeutics
• Collaborators: Emerald Clinical Trials
• Investigators: Study Director: Dr. Leanne Barnett, Leanne.barnett@nzcr.co.nz, New Zealand Clinical Research (NZCR)

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Healthy Volunteers; Randomized; Double-blind; Tolerability; First-in-human; Single Ascending Dose; Multiple Ascending Dose; AKB-9090; Single-centre
• Other Study ID Numbers: AKB-9090-CI-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No