Single- and multiple-dose testing of AKB-9090 in healthy adults
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
Run by Akebia Therapeutics · NCT07429006 · Data updated 2026-11-12
This will test whether single and multiple doses of AKB-9090 are safe and how the body processes the drug in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 44 (estimated) |
| Sponsor | Akebia Therapeutics Industry-sponsored |
| Locations | 1 site (Auckland) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | October 6, 2026 |
| Trial ID | NCT07429006 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults with BMI 18.5–32.0 kg/m2, no clinically significant medical findings on screening tests, and willing to comply with confinement and study visit requirements are ideal candidates.
✕Probably not a fit
People with significant medical conditions, abnormal screening tests, or who cannot comply with study confinement and visit schedules are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This first-in-human, phase 1 single-centre study will enroll about 40 participants in a single ascending dose (SAD) phase across five cohorts and about 30 participants in a multiple ascending dose (MAD) phase across three cohorts. Participants will receive AKB-9090 or placebo with safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) measurements collected during confinement and subsequent outpatient visits. Dosing begins at a low level and is escalated between cohorts with safety reviews guiding dose increases. The study aims to define dose-related effects and PK/PD profiles in healthy adults to inform later patient-focused trials.
Why it matters
Potential benefit: If successful, the study could identify safe dose ranges and PK/PD characteristics to support further clinical development of AKB-9090.
How similar studies have gone: This is the first-in-human trial for AKB-9090, though SAD and MAD designs are standard and have successfully guided dose selection for many other investigational drugs.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Investigator Site #1
Auckland, New Zealand Recruiting
Study contacts
- Study coordinator: Dr. Sophie Mckellar
- Email: sophie.mckellar@nzcr.co.nz
- Phone: +64 9 373 3474
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.