NCT07429006 SAD and MAD Study of AKB-9090 in Healthy Adult Participants
| NCT ID | NCT07429006 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Akebia Therapeutics |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 44 participants in total. It began in 2026-03-16 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Dr. Sophie Mckellar sophie.mckellar@nzcr.co.nz
STUDY DIRECTOR
New Zealand Clinical Research (NZCR)
Frequently Asked Questions
Who can join the NCT07429006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07429006 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07429006 currently recruiting?
Yes, NCT07429006 is actively recruiting participants. Contact the research team at sophie.mckellar@nzcr.co.nz for enrollment information.
Where is the NCT07429006 trial being conducted?
This trial is being conducted at Auckland, New Zealand.
Who is sponsoring the NCT07429006 clinical trial?
NCT07429006 is sponsored by Akebia Therapeutics. The principal investigator is Dr. Sophie Mckellar sophie.mckellar@nzcr.co.nz at New Zealand Clinical Research (NZCR). The trial plans to enroll 44 participants.