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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06905327




Registration number
NCT06905327
Ethics application status
Date submitted
25/03/2025
Date registered
1/04/2025

Titles & IDs
Public title
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
Scientific 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
Secondary ID [1] 0 0
BW-00163-1002
Secondary ID [2] 0 0
CQCZ484A02101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QCZ484
Treatment: Drugs - Placebo

Experimental: Part A: QCZ484 50 mg - Healthy Cohort: single dose

Experimental: Part A: QCZ484 150 mg - Healthy Cohort: single dose

Experimental: Part A: QCZ484 300 mg - Healthy Cohort: single dose

Experimental: Part A: QCZ484 600 mg - Healthy Cohort: single dose

Placebo comparator: Part A: QCZ484 Placebo - Healthy Cohort: single dose

Experimental: Part B: QCZ484 150 mg - Hypertension Cohort: single dose

Experimental: Part B: QCZ484 300 mg - Hypertension Cohort: single dose

Experimental: Part B: QCZ484 600 mg - Hypertension Cohort: single dose

Placebo comparator: Part B: QCZ484 Placebo - Hypertension Cohort: single dose


Treatment: Drugs: QCZ484
doses of 50, 150, 300 or 600 mg via subcutaneous injection

Treatment: Drugs: Placebo
via subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adverse events (AEs)
Timepoint [1] 0 0
Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose.
Primary outcome [2] 0 0
Number of participants with abnormalities in any laboratory parameter
Timepoint [2] 0 0
Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose
Secondary outcome [1] 0 0
Number of AEs
Timepoint [1] 0 0
up to 48 weeks post dose
Secondary outcome [2] 0 0
Number of participants with abnormalities in any laboratory parameter
Timepoint [2] 0 0
up to 48 weeks post dose
Secondary outcome [3] 0 0
Plasma pharmacokinetics of QCZ484 and metabolites - Cmax
Timepoint [3] 0 0
Day 1; up to Day 8
Secondary outcome [4] 0 0
Plasma pharmacokinetics of QCZ484 - Tmax
Timepoint [4] 0 0
Day 1; up to Day 8
Secondary outcome [5] 0 0
Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48
Timepoint [5] 0 0
Day 1; up to Day 8
Secondary outcome [6] 0 0
Plasma pharmacokinetics of QCZ484 - AUC0-inf
Timepoint [6] 0 0
Day 1; up to Day 8
Secondary outcome [7] 0 0
Plasma pharmacokinetics of QCZ484 - T1/2
Timepoint [7] 0 0
Day 1; up to Day 8
Secondary outcome [8] 0 0
Urine pharmacokinetics of QCZ484
Timepoint [8] 0 0
Day 1; up to Day 2
Secondary outcome [9] 0 0
Change from baseline in serum angiotensinogen (AGT) level
Timepoint [9] 0 0
up to 48 weeks post dose

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/08/2025
Actual
Sample size
Target
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [2] 0 0
Novartis Investigative Site - Morayfield
Recruitment hospital [3] 0 0
Novartis Investigative Site - Adelaide
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment postcode(s) [2] 0 0
4506 - Morayfield
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06905327