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

NCT07429006 | Recruiting Phase 1 DMC

• 1 other identifier: AKB-9090-CI-0001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Healthy Volunteers

Keywords

AKB-9090; Single-centre; Single Ascending Dose; Multiple Ascending Dose; First-in-human; Safety; Tolerability; Randomized; Double-blind; Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (18)

• 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

Study Arms (2)

AKB-9090

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Single IV dose of matching Placebo.

Other: Placebo

Interventions

AKB-9090 DRUG

AKB-9090 will be administered intravenously

AKB-9090

Placebo OTHER

Matching Placebo administered intravenously

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Akebia Therapeutics: lead
• Emerald Clinical Trials: collaborator

Study Sites (1)

Investigator Site #1

Auckland, New Zealand

RECRUITING

Study Officials

• Dr. Leanne Barnett, Leanne.barnett@nzcr.co.nz

  New Zealand Clinical Research (NZCR)

  STUDY DIRECTOR

Central Study Contacts

Dr. Leanne Barnett

CONTACT

+64 9 373 3474; propeller.auckland@nzcr.co.nz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)