Testing HJB647 for safety in Japanese adults with high blood pressure
Tests HJB647 for safety in Japanese adults with elevated blood pressure or hypertension.
Plain-language title generated from the registry record
Registry title: HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
Key facts
- Where
- Sumida-ku, JapanSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07644364, who can take part
Where in Japan
- Sumida-kuSumida-ku, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07644364
- Record updated
- 22 July 2026
- Original description
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 HJB647Read full original descriptionShow less
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
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
Inclusion: 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: Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline; 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; 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; Women of childbearing potential; Other protocol-defined inclusion/exclusion criteria may apply.