Last Update: Jul 22, 2026 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 ClinicalTrials.gov Identifier: [NCT07644364](https://clinicaltrials.gov/ct2/show/NCT07644364) Novartis Reference Number:CHJB647A11101 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study 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 HJB647 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. Condition Elevated Blood Pressure, Hypertension Phase Phase1 Overall Status Recruiting Number of Participants64 Start Date Jul 02, 2026 Completion Date Dec 25, 2026 Gender All Age(s) 18 Years - 60 Years (Adult) ## Interventions Drug ### HJB647 HJB647 oral capsule Drug ### Placebo Matching oral placebo ## 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 Japan #### Novartis Investigative Site Recruiting Sumida Ku,Tokyo,1300004,Japan ## Worldwide Contacts If the location of your choosing does not feature any contact detail, please reach out using the information below. #### Novartis Pharmaceuticals Phone: [ +81337978748](tel:+81337978748) Email: