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

RecruitingPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Elevated Blood Pressure, Hypertension

Interventions: HJB647, Placebo

Countries: Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (1)

Sumida Ku, Tokyo, Japan