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

NCT07644364 | Not Yet Recruiting Phase 1

• 1 other identifier: CHJB647A11101
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Elevated Blood Pressure; Hypertension

Keywords

HJB647; safety; tolerability; pharmacokinetics; Japanese participants with elevated blood pressure; Japanese patients with hypertension

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (11)

• Part 1: Number of participants with AEs

  Up to 27 days

• Part 2: Cmax

  Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21

• Part 2: Tmax

  Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21

• Part 2: AUClast

  Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21

• Part 2: AUCinf

  Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21

Study Arms (10)

Part 1-1: HJB647 low dose

EXPERIMENTAL

Single dose Day 1 in Part 1

Drug: HJB647

Part 1-2: HJB647 mid-dose

EXPERIMENTAL

Single dose Day 1 in Part 1

Drug: HJB647

Part 1-3: HJB647 high dose

EXPERIMENTAL

Single dose Day 1 in Part 1

Drug: HJB647

Part 1: Placebo

PLACEBO COMPARATOR

Single dose Day 1 in Part 1

Drug: Placebo

Part 2-1: HJB647 multiple oral doses

EXPERIMENTAL

Multiple oral doses of HJB647 with adaptive up-titration in Part 2

Drug: HJB647

Part 2-2: HJB647 multiple oral doses (optional cohort)

EXPERIMENTAL

Multiple oral doses of HJB647 with adaptive up-titration in Part 2

Drug: HJB647

Part 2-3: HJB647 multiple oral doses (optional cohort)

EXPERIMENTAL

Multiple oral doses of HJB647 with adaptive up-titration in Part 2

Drug: HJB647

Part 2-4: HJB647 multiple oral doses (optional cohort)

EXPERIMENTAL

Multiple oral doses of HJB647 with adaptive up-titration in Part 2

Drug: HJB647

Part 2-5: HJB647 multiple oral doses (optional cohort)

EXPERIMENTAL

Multiple oral doses of HJB647 with adaptive up-titration in Part 2

Drug: HJB647

Part 2: Placebo

PLACEBO COMPARATOR

Multiple oral doses of placebo with adaptive up-titration in Part 2

Drug: Placebo

Interventions

HJB647 DRUG

HJB647 oral capsule

Part 1-1: HJB647 low dose; Part 1-2: HJB647 mid-dose; Part 1-3: HJB647 high dose; Part 2-1: HJB647 multiple oral doses; Part 2-2: HJB647 multiple oral doses (optional cohort); Part 2-3: HJB647 multiple oral doses (optional cohort); Part 2-4: HJB647 multiple oral doses (optional cohort); Part 2-5: HJB647 multiple oral doses (optional cohort)

Placebo DRUG

Matching oral placebo

Part 1: Placebo; Part 2: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+81337978748; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): June 23, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): January 20, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share