💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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