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Recruiting
NCT07429006
SAD and MAD Study of AKB-9090 in Healthy Adult Participants
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 44
Sponsor: Akebia Therapeutics
Location: Investigator Site #1 Auckland
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 \
Source: ClinicalTrials.gov (NCT07429006). StuddyBuddy aggregates publicly available trial information.