Status:
COMPLETED
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Mild Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
Phase 1, multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of QCZ484. In Part A, single ascending doses of QCZ4...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06905327
Start Date
March 8 2023
End Date
July 1 2025
Last Update
December 4 2025
Active Locations (4)
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1
Novartis Investigative Site
Herston, Queensland, Australia, 4006
2
Novartis Investigative Site
Morayfield, Queensland, Australia, 4506
3
Novartis Investigative Site
Adelaide, Australia, 5000
4
Novartis Investigative Site
Auckland, New Zealand, 0622