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

April 7, 2026 updated by: Akebia Therapeutics

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Physical Examinations
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Chemistry parameters
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Hematology Parameters
Time Frame: from first dose to Day 7
from first dose to Day 7
Number of Participants with Clinically Significant Changes in Lipid Parameters
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Coagulation Parameters
Time Frame: From First Dose to Day 7
From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Urinalysis Parameters
Time Frame: From First Dose to Day 7
From First Dose to Day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 2 MAD Cohorts: Cmax of AKB-9090
Time Frame: At Day 1 and Day 7
At Day 1 and Day 7
Stage 2 MAD Cohorts: Tmax of AKB-9090
Time Frame: At Day 1 and Day 7
At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090
Time Frame: At Day 1
At Day 1
Stage 2 MAD Cohorts: CL of AKB-9090
Time Frame: At Day 1 and Day 7
At Day 1 and Day 7
Stage 2 MAD Cohorts: T1/2 of AKB-9090
Time Frame: At Day 1 and Day 7
At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090
Time Frame: At Day 7
At Day 7
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Erythropoietin (EPO)
Time Frame: Baseline (Day 1) and at 6, 12, 18, and 24 hours post-dose
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)
Time Frame: Baseline (Day 1) and At Day 2
Baseline (Day 1) and At Day 2
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Time Frame: Baseline (Day 1) and At Day 2
Baseline (Day 1) and At Day 2
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - EPO
Time Frame: Baseline (Day 1 and Day 7) and at 6, 12, 18, and 24 hours post-dose
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
Time Frame: Baseline (Day 1) and At Days 4 and 8
Baseline (Day 1) and At Days 4 and 8
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Time Frame: Baseline (Day 1) and At Days 4 and 8
Baseline (Day 1) and At Days 4 and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akebia Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emerald Clinical Trials

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dr. Leanne Barnett, Leanne.barnett@nzcr.co.nz, New Zealand Clinical Research (NZCR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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