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Phase 1
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID07644364

Phase 1b Randomized Study of HJB647 in Japanese Adults with Elevated Blood Pressure and Hypertension Evaluating Safety, Tolerability, and Pharmacokinetics

Led by Novartis Pharmaceuticals · Updated on 2026-07-22

64

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and how the body processes and responds to HJB647 in Japanese adults with elevated blood pressure and hypertension. This randomized, placebo-controlled, double-blind Phase 1b study includes healthy participants with elevated blood pressure and patients with mild-to-moderate hypertension to support future development of HJB647. The study has two parts Part 1 tests a single oral dose of HJB647 in healthy participants using sentinel dosing within each cohort, while Part 2 involves multiple oral doses with adaptive dose escalation and up-titration in hypertensive patients. Both parts include placebo groups for comparison. Participants will be monitored through scheduled visits with assessments including blood pressure and heart rate measurements, pharmacokinetic and pharmacodynamic evaluations, and safety reviews. Part 1 outcomes focus on drug concentration and timing measures after a single dose, while Part 2 monitors adverse events and changes in blood pressure and heart rate up to 51 days. The study runs from July to December 2026.

CONDITIONS

Brief Title

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

Research Team

N

Novartis Pharmaceuticals

N

Novartis Pharmaceuticals

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