Clinical trial NCT06905327: A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Mild Hypertension
Keywords: Hypertension
QCZ484
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-04-01
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 QCZ484 are tested in healthy subjects, while in Part B, single doses of QCZ484 are tested in subjects with mild hypertension. One dose of QCZ484 is administered subcutaneously.

This study was started by Argo Biopharma, and global sponsorship was transferred to Novartis.

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.

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose.
measure: Number of participants with abnormalities in any laboratory parameter
timeFrame: Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose
Secondary outcomes:
measure: Number of AEs
timeFrame: up to 48 weeks post dose
measure: Number of participants with abnormalities in any laboratory parameter
timeFrame: up to 48 weeks post dose
measure: Plasma pharmacokinetics of QCZ484 and metabolites - Cmax
timeFrame: Day 1; up to Day 8
measure: Plasma pharmacokinetics of QCZ484 - Tmax
timeFrame: Day 1; up to Day 8
measure: Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48
timeFrame: Day 1; up to Day 8
measure: Plasma pharmacokinetics of QCZ484 - AUC0-inf
timeFrame: Day 1; up to Day 8
measure: Plasma pharmacokinetics of QCZ484 - T1/2
timeFrame: Day 1; up to Day 8
measure: Urine pharmacokinetics of QCZ484
timeFrame: Day 1; up to Day 2
measure: Change from baseline in serum angiotensinogen (AGT) level
timeFrame: up to 48 weeks post dose
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Morayfield
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
city: Auckland
country: New Zealand
facility: Novartis Investigative Site
Study officials:
References: