HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovartis Pharmaceuticals
About this trial
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
Eligibility criteria
Qualifiers
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)
Male: ≥ 50.0 kg
Female: ≥ 45.0 kg
Disqualifiers
Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline
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
Trial design
Treatments tested in this trial
- HJB647
- Placebo
Treatment groups
74 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Locations
Sponsors and collaborators
Source ClinicalTrials.gov