NCT06905327

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2023

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.6 years

First QC Date

March 25, 2025

Last Update Submit

November 27, 2025

Conditions

Mild Hypertension

Keywords

HypertensionQCZ484

Outcome Measures

Primary Outcomes (2)

  • Number of adverse events (AEs)

    Overall number of AEs, severity, and relationship to study treatment per treatment group.

    Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose.

  • Number of participants with abnormalities in any laboratory parameter

    Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis)

    Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose

Secondary Outcomes (9)

  • Number of AEs

    up to 48 weeks post dose

  • Number of participants with abnormalities in any laboratory parameter

    up to 48 weeks post dose

  • Plasma pharmacokinetics of QCZ484 and metabolites - Cmax

    Day 1; up to Day 8

  • Plasma pharmacokinetics of QCZ484 - Tmax

    Day 1; up to Day 8

  • Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48

    Day 1; up to Day 8

  • +4 more secondary outcomes

Study Arms (9)

Part A: QCZ484 50 mg

EXPERIMENTAL

Healthy Cohort: single dose

Drug: QCZ484

Part A: QCZ484 150 mg

EXPERIMENTAL

Healthy Cohort: single dose

Drug: QCZ484

Part A: QCZ484 300 mg

EXPERIMENTAL

Healthy Cohort: single dose

Drug: QCZ484

Part A: QCZ484 600 mg

EXPERIMENTAL

Healthy Cohort: single dose

Drug: QCZ484

Part A: QCZ484 Placebo

PLACEBO COMPARATOR

Healthy Cohort: single dose

Drug: Placebo

Part B: QCZ484 150 mg

EXPERIMENTAL

Hypertension Cohort: single dose

Drug: QCZ484

Part B: QCZ484 300 mg

EXPERIMENTAL

Hypertension Cohort: single dose

Drug: QCZ484

Part B: QCZ484 600 mg

EXPERIMENTAL

Hypertension Cohort: single dose

Drug: QCZ484

Part B: QCZ484 Placebo

PLACEBO COMPARATOR

Hypertension Cohort: single dose

Drug: Placebo

Interventions

QCZ484DRUG

doses of 50, 150, 300 or 600 mg via subcutaneous injection

Part A: QCZ484 150 mgPart A: QCZ484 300 mgPart A: QCZ484 50 mgPart A: QCZ484 600 mgPart B: QCZ484 150 mgPart B: QCZ484 300 mgPart B: QCZ484 600 mg
PlaceboDRUG

via subcutaneous injection

Part A: QCZ484 PlaceboPart B: QCZ484 Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Herston, Queensland, 4006, Australia

Location

Novartis Investigative Site

Morayfield, Queensland, 4506, Australia

Location

Novartis Investigative Site

Adelaide, 5000, Australia

Location

Novartis Investigative Site

Auckland, 0622, New Zealand

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

March 8, 2023

Primary Completion

September 25, 2024

Study Completion

July 1, 2025

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)NZ(1)