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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат AKB-9090
  AKB-9090 will be administered intravenously
• Другое Placebo
  Matching Placebo administered intravenously

Первичные конечные точки

• Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Physical Examinations [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Vital Signs [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Chemistry parameters [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Hematology Parameters [Срок оценки: from first dose to Day 7]
• Number of Participants with Clinically Significant Changes in Lipid Parameters [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Coagulation Parameters [Срок оценки: From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Urinalysis Parameters [Срок оценки: From First Dose to Day 7]

Вторичные конечные точки (12)

• Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090 [Срок оценки: At Day 1]
• Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090 [Срок оценки: At Day 1]
• Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090 [Срок оценки: At Day 1]
• Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090 [Срок оценки: At Day 1]
• Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090 [Срок оценки: At Day 1]
• Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090 [Срок оценки: At Day 1]
• Stage 2 MAD Cohorts: Cmax of AKB-9090 [Срок оценки: At Day 1 and Day 7]
• Stage 2 MAD Cohorts: Tmax of AKB-9090 [Срок оценки: At Day 1 and Day 7]
• Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090 [Срок оценки: At Day 1]
• Stage 2 MAD Cohorts: CL of AKB-9090 [Срок оценки: At Day 1 and Day 7]
• Stage 2 MAD Cohorts: T1/2 of AKB-9090 [Срок оценки: At Day 1 and Day 7]
• Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090 [Срок оценки: At Day 7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Новая Зеландия · 1 центр

• Investigator Site #1 — Auckland

Идентификаторы

NCT: NCT07429006 · AKB-9090-CI-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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