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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07644364
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • HJB647 — DRUG
    HJB647 oral capsule
  • Placebo — DRUG
    Matching oral placebo

Study Details

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

Key Dates

First listed
Jun 12, 2026
Start date
Jul 2, 2026
Status verified
Jul 2026
Primary completion
Dec 25, 2026
Completion
Dec 25, 2026

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1-1: HJB647 low dose
    Single dose Day 1 in Part 1
  • Experimental: Part 1-2: HJB647 mid-dose
    Single dose Day 1 in Part 1
  • Experimental: Part 1-3: HJB647 high dose
    Single dose Day 1 in Part 1
  • Placebo Comparator: Part 1: Placebo
    Single dose Day 1 in Part 1
  • Experimental: Part 2-1: HJB647 multiple oral doses
    Multiple oral doses of HJB647 with adaptive up-titration in Part 2
  • Experimental: Part 2-2: HJB647 multiple oral doses (optional cohort)
    Multiple oral doses of HJB647 with adaptive up-titration in Part 2
  • Experimental: Part 2-3: HJB647 multiple oral doses (optional cohort)
    Multiple oral doses of HJB647 with adaptive up-titration in Part 2
  • Experimental: Part 2-4: HJB647 multiple oral doses (optional cohort)
    Multiple oral doses of HJB647 with adaptive up-titration in Part 2
  • Experimental: Part 2-5: HJB647 multiple oral doses (optional cohort)
    Multiple oral doses of HJB647 with adaptive up-titration in Part 2
  • Placebo Comparator: Part 2: Placebo
    Multiple oral doses of placebo with adaptive up-titration in Part 2

Primary Outcome Measure

Part 1: Cmax [ Time Frame: Part 1 on Day 1 ]

Central Contacts

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