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A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects

NCT06905327

CompletedPhase 1

Sponsor: Novartis Pharmaceuticals

Conditions: Mild Hypertension

Interventions: QCZ484, Placebo

Countries: Australia, New Zealand

This is a randomized, double-blind, placebo-controlled study including Part A single ascending dose (SAD) in healthy subjects and Part B single dose in subjects with mild hypertension.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Healthy males or females aged 18 to 60 years, inclusive, at the time of informed consent. (Part A only).
* Males or females aged 18 to 72 years, inclusive, at the time of informed consent (Part B only).
* Body mass index (BMI) \>= 18 and \<= 32 kg/m2 and body weight \>50 kg (Part A only).
* Body mass index (BMI) \>=18 and \<=35 kg/m2 and body weight \>50 kg (Part B only).
* Triplicate 12-lead electrocardiogram (ECG) after \>5 minutes resting without clinically significant findings at screening and Day -1.
* Mean sitting systolic blood pressure (SBP) of \>=130 and \<160 mm Hg (Part B only).

Exclusion Criteria:

* History of hypotension or orthostatic hypotension.
* History of syncope within 1 year.
* SBP \<90 mmHg or DBP \<60 mm Hg at screening (Part A only).
* Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening.
* Any liver function panel analyte value \> 1.2 ×upper limits of normal (ULN) at screening.
Locations (4)
  • Herston, Queensland, Australia
  • Morayfield, Queensland, Australia
  • Adelaide, Australia
  • Auckland, New Zealand