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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Elevated Blood Pressure
• Intervention / Treatment: Drug: Placebo; Drug: HJB647

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +81337978748; Email: Novartis.email@novartis.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1-1: HJB647 low dose; Single dose Day 1 in Part 1	Drug: HJB647; HJB647 oral capsule
Experimental: Part 1-2: HJB647 mid-dose; Single dose Day 1 in Part 1	Drug: HJB647; HJB647 oral capsule
Experimental: Part 1-3: HJB647 high dose; Single dose Day 1 in Part 1	Drug: HJB647; HJB647 oral capsule
Placebo Comparator: Part 1: Placebo; Single dose Day 1 in Part 1	Drug: Placebo; Matching oral placebo
Experimental: Part 2-1: HJB647 multiple oral doses; Multiple oral doses of HJB647 with adaptive up-titration in Part 2	Drug: HJB647; HJB647 oral capsule
Experimental: Part 2-2: HJB647 multiple oral doses (optional cohort); Multiple oral doses of HJB647 with adaptive up-titration in Part 2	Drug: HJB647; HJB647 oral capsule
Experimental: Part 2-3: HJB647 multiple oral doses (optional cohort); Multiple oral doses of HJB647 with adaptive up-titration in Part 2	Drug: HJB647; HJB647 oral capsule
Experimental: Part 2-4: HJB647 multiple oral doses (optional cohort); Multiple oral doses of HJB647 with adaptive up-titration in Part 2	Drug: HJB647; HJB647 oral capsule
Experimental: Part 2-5: HJB647 multiple oral doses (optional cohort); Multiple oral doses of HJB647 with adaptive up-titration in Part 2	Drug: HJB647; HJB647 oral capsule
Placebo Comparator: Part 2: Placebo; Multiple oral doses of placebo with adaptive up-titration in Part 2	Drug: Placebo; Matching oral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Cmax	Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)	Part 1 on Day 1
Part 1: Tmax	Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)	Part 1 on Day 1
Part 1: AUClast	AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)	Part 1 on Day 1
Part 1: AUCinf	AUCinf: The AUC from time zero to infinity (mass x time x volume-1)	Part 1 on Day 1
Part 1: AUCtau	AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)	Part 1 on Day 1
Part 1: T1/2	T1/2: The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives	Part 1 on Day 1
Part 2: Number of participants with AEs	Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters	Up to 51 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of participants with AEs	Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters	Up to 27 days
Part 2: Cmax	Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Tmax	Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUClast	AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCinf	AUCinf: The AUC from time zero to infinity (mass x time x volume-1)	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCtau	AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: T1/2	T1/2: The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Office blood pressure change from baseline		Baseline to Day 27 of part 2
Part 2: Heart rate change from baseline		Baseline to Day 27 of part 2
Part 2: Change in 24-hr mean SBP/DBP	Change in 24-hr mean Systolic Blood Pressure (SBP)/Diastolic Blood Pressure (DBP), daytime and night time mean Blood Pressure (BP)	Part 2 Day 1, Day 7, Day 8, Day 14, Day 15, Day 21 and Day 22
Part 2: Mean Blood Pressure	Daytime mean BP, and nighttime mean BP (ambulatory blood pressure monitoring)	27 days

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tolerability; safety; pharmacokinetics; HJB647; Japanese participants with elevated blood pressure; Japanese patients with hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: CHJB647A11101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No