NCT06905327CompletedPhase 1
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered QCZ484 in Healthy Subjects and Subjects With Mild Hypertension
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 25 Mar 2025
- Start date
- Mar 2023
- Primary completion date
- Sept 2024
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- High blood pressure
- NCT number
- NCT06905327
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 56
- From Mar 2023 to the primary completion date, Sept 2024
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of hypotension or orthostatic hypotension.
- History of syncope within 1 year.
Lab values
- 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.
Other
- SBP \<90 mmHg or DBP \<60 mm Hg at screening (Part A only).
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Morayfield | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.