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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 (CHJB647A11101)

HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension (CHJB647A11101)

Sato Mika

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Sato Mika

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Recruiting

July. 02, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 celsius degree
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

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

Both

Healthy Participants With Elevated Blood Pressure and Patients With Hypertension

Par1:
Experimental: Single oral doses (low, mid, high) of HJB647
Placebo Comparator: Single oral dose of placebo
Part2:
Experimental: Multiple oral doses of HJB647 with adaptive up-titration
Placebo Comparator: Multiple oral doses of placebo

Part 1: Cmax, Tmax, AUClast, AUCinf, AUCtau, T1/2
Part 2: Number of participants with AEs

April. 16, 2026

No

none