HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension

Официальное название

A Phase 1b, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HJB647 Following Single Ascending Dose and Up-titration Multiple Dose Administration in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension

Обзор

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood pressure and multiple dose administration with up titration in Japanese patients with hypertension, to support future clinical development of HJB647

Подробное описание

Randomized, placebo-controlled, participant- and investigator-blind study consisting of two parts:

* Part 1 (SAD part): Single oral dose in healthy participants. Sentinel dosing will be applied in each cohort. * Part 2 (MAD part): Multiple oral doses in patients with hypertension. Safety reviews will guide dose escalation and up-titration.

Вмешательства

• Препарат HJB647
  HJB647 oral capsule
• Препарат Placebo
  Matching oral placebo

Первичные конечные точки

• Part 1: Cmax [Срок оценки: Part 1 on Day 1]
• Part 1: Tmax [Срок оценки: Part 1 on Day 1]
• Part 1: AUClast [Срок оценки: Part 1 on Day 1]
• Part 1: AUCinf [Срок оценки: Part 1 on Day 1]
• Part 1: T1/2 [Срок оценки: Part 1 on Day 1]
• Part 2: Number of participants with AEs [Срок оценки: Up to 51 days]

Вторичные конечные точки (9)

• Part 1: Number of participants with AEs [Срок оценки: Up to 31 days]
• Part 2: Cmax [Срок оценки: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
• Part 2: Tmax [Срок оценки: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
• Part 2: AUClast [Срок оценки: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
• Part 2: AUCinf [Срок оценки: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
• Part 2: AUCtau [Срок оценки: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
• Part 2: T1/2 [Срок оценки: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
• Part 2: Office blood pressure change from baseline [Срок оценки: Baseline to Day 27 of part 2]
• Part 2: Heart rate change from baseline [Срок оценки: Baseline to Day 27 of part 2]

Критерии участия

Критерии включения

• Japanese healthy participants with elevated blood pressure (Part 1) and patients with mild-to-moderate hypertension (Part 2)
• Age: 18 to 55 years (Part 1) and 18 to 60 years (Part 2)
• Body weight:

• Male: ≥ 50.0 kg
• Female: ≥ 45.0 kg
• Body Mass Index (BMI): 18.0 to 30.0 kg/m²
• Axillary body temperature: 35.0-37.5 °C
• Heart rate: 50-90 bpm
• Blood pressure criteria are as follows:

• Part 1: Healthy Participants with Elevated Blood Pressure Screening: Systolic Blood Pressure (SBP): 120 ≤ SBP ≤ 139 mmHg; Diastolic Blood Pressure (DBP): 60 ≤ DBP ≤ 94 mmHg Baseline (Day -1): SBP: 120 ≤ SBP ≤ 179 mmHg; DBP: 60 ≤ DBP ≤ 109 mmHg
• Part 2: Patients with Hypertension Screening and Baseline (Day -1): SBP: 140 ≤ SBP ≤ 179 mmHg; DBP: 60 ≤ DBP ≤ 109 mmHg

Критерии исключения

• Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline
• History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as:

• Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker.
• History of familial long QT syndrome or known family history of Torsades de Pointes
• Resting QT interval corrected by Fridericia's formula (QTcF) ≥ 450 msec (male) or ≥ 460 msec (female) at screening
• At screening, hypokalemia or hypomagnesemia defined as potassium or magnesium values below the LLN on repeat measurement, or laboratory abnormalities indicating hypothyroidism, as determined at the discretion of the investigator
• HbA1c ≥ 7.0% or LDL cholesterol ≥ 180 mg/dL or triglycerides ≥ 250 mg/dL
• Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or OTC medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing
• Women of childbearing potential

Other protocol-defined inclusion/exclusion criteria may apply

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Япония · 1 центр

• Novartis Investigative Site — Sumida Ku

Идентификаторы

NCT: NCT07644364 · CHJB647A11101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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