Healthy VolunteersPhase 1NCT07429006
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
A Phase 1 study testing AKB-9090 in people with Healthy Volunteers, run by Akebia Therapeutics at 1 site in New Zealand.
Trial summary
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 four dose cohorts, and Stage 2, a multiple ascending dose (MAD)… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AKB-9090
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteNew Zealand
- Study dates
- 16 Mar 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
- Treated basal cell carcinoma of the skin
- Curatively resected squamous cell carcinoma of the skin
- Treated colonic or cervical carcinoma in situ
- Abnormal ECG findings at screening, including:
Show all 11Show fewer
- Severe bradycardia (heart rate <40 beats per minute) on any measurement
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 four dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with one dose cohort. Approximately 32 participants in SAD and 12 in MAD are planned to be enrolled.
- Conditions
- Healthy Volunteers
- Being tested
- AKB-9090, Placebo
- Keywords
- AKB-9090, Single-centre, Single Ascending Dose, Multiple Ascending Dose, First-in-human, Safety, Tolerability, Randomized, Double-blind, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-9090Drug
AKB-9090 will be administered intravenously
PlaceboOther
Matching Placebo administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| AKB-9090 | Experimental | Participants will receive a single intravenous (IV) dose of AKB-9090 at 4 escalating dose levels in the SAD stage and at 1 dose level in the MAD stage. Receives: Drug: AKB-9090 |
| Placebo | Placebo comparator | Single IV dose of matching Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Physical Examinations
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Vital Signs
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Chemistry parameters
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Hematology Parameters
Measured: from first dose to Day 7
Number of Participants with Clinically Significant Changes in Lipid Parameters
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Coagulation Parameters
Measured: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Urinalysis Parameters
Measured: From First Dose to Day 7
Secondary outcomes (18)
Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090
Measured: At Day 1
Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090
Measured: At Day 1
Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090
Measured: At Day 1
Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090
Measured: At Day 1
Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090
Measured: At Day 1
Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090
Measured: At Day 1
Stage 2 MAD Cohorts: Cmax of AKB-9090
Measured: At Day 1 and Day 7
Stage 2 MAD Cohorts: Tmax of AKB-9090
Measured: At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090
Measured: At Day 1
Stage 2 MAD Cohorts: CL of AKB-9090
Measured: At Day 1 and Day 7
Stage 2 MAD Cohorts: T1/2 of AKB-9090
Measured: At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090
Measured: At Day 7
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Erythropoietin (EPO)
Measured: 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)
Measured: Baseline (Day 1) and At Days 2, 8, and 13
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Measured: Baseline (Day 1) and At Days 2, 8, and 13
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - EPO
Measured: 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
Measured: Baseline (Day 1) and At Days 4, 8, 14, and 21
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Measured: Baseline (Day 1) and At Days 4, 8, 14, and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start16 Mar 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Dr. Sophie Mckellar sophie.mckellar@nzcr.co.nz, Study director, New Zealand Clinical Research (NZCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429006
- Sponsor's protocol ID
- AKB-9090-CI-0001
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07429006
- Acronym / sponsor ID
- AKB-9090-CI-0001
- Conditions
- Healthy Volunteers
- Keywords
- AKB-9090, Single-centre, Single Ascending Dose, Multiple Ascending Dose, First-in-human, Safety, Tolerability, Randomized
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Trials
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 four dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with one dose cohort. Approximately 32 participants in SAD and 12 in MAD are planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKB-9090 | Experimental | Drug: AKB-9090Participants will receive a single intravenous (IV) dose of AKB-9090 at 4 escalating dose levels in the SAD stage and at 1 dose level in the MAD stage. |
| Placebo | Placebo comparator | Other: PlaceboSingle IV dose of matching Placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (11 listed)
- 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:
- Abnormal ECG findings at screening, including:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKB-9090AKB-9090 will be administered intravenously | Drug | AKB-9090 |
| PlaceboMatching Placebo administered intravenously | Other | Placebo |
Primary outcome
Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Physical Examinations
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: 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
Number of Participants with Clinically Significant Changes in Chemistry parameters
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Hematology Parameters
Time frame: from first dose to Day 7
Number of Participants with Clinically Significant Changes in Lipid Parameters
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Coagulation Parameters
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Urinalysis Parameters
Time frame: From First Dose to Day 7
18 secondary outcomes
Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090
Time frame: 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
Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090
Time frame: At Day 1
Stage 2 MAD Cohorts: Cmax of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: Tmax of AKB-9090
Time frame: 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
Stage 2 MAD Cohorts: CL of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: T1/2 of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090
Time frame: 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
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Red Blood Cell Count (RBC)
Time frame: Baseline (Day 1) and At Days 2, 8, and 13
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Time frame: Baseline (Day 1) and At Days 2, 8, and 13
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
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - RBC
Time frame: Baseline (Day 1) and At Days 4, 8, 14, and 21
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Time frame: Baseline (Day 1) and At Days 4, 8, 14, and 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Sophie Mckellar sophie.mckellar@nzcr.co.nz study director
New Zealand Clinical Research (NZCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AKB-9090 in people with Healthy Volunteers, run by Akebia Therapeutics at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Sophie Mckellar (+64 9 373 3474, sophie.mckellar@nzcr.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs (time frame: From First Dose to Day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.