HJB647 in Japanese adults with elevated blood pressure and hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, placebo-controlled, double-blind study conducted in two parts. Part 1 tests a single oral dose in Japanese healthy participants with elevated blood pressure, with sentinel dosing in each cohort. Part 2 tests multiple oral doses in Japanese patients with mild-to-moderate hypertension, using safety reviews to guide dose escalation and up-titration. The study aims to characterize safety, tolerability, pharmacokinetics, and pharmacodynamics of HJB647 to support future development.

Why it matters

Who can join: the full rules

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

Where it's running

• Novartis Investigative Site
  Sumida Ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +81337978748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.