Mild HypertensionPhase 1NCT06905327
A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects
A Phase 1 study testing QCZ484 in people with Mild Hypertension, run by Novartis Pharmaceuticals at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Hypertension
- What is being tested?
- QCZ484
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 8 Mar 2023to 1 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Novartis Investigative Site
Adelaide, 5000
Novartis Investigative Site
Herston, Queensland, 4006
Novartis Investigative Site
Morayfield, Queensland, 4506
About this study
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
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.
Read the 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.
- Conditions
- Mild Hypertension
- Being tested
- QCZ484, Placebo
- Keywords
- Hypertension, QCZ484
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QCZ484Drug
doses of 50, 150, 300 or 600 mg via subcutaneous injection
PlaceboDrug
via subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: QCZ484 50 mg | Experimental | Healthy Cohort: single dose Receives: Drug: QCZ484 |
| Part A: QCZ484 150 mg | Experimental | Healthy Cohort: single dose Receives: Drug: QCZ484 |
| Part A: QCZ484 300 mg | Experimental | Healthy Cohort: single dose Receives: Drug: QCZ484 |
| Part A: QCZ484 600 mg | Experimental | Healthy Cohort: single dose Receives: Drug: QCZ484 |
| Part A: QCZ484 Placebo | Placebo comparator | Healthy Cohort: single dose Receives: Drug: Placebo |
| Part B: QCZ484 150 mg | Experimental | Hypertension Cohort: single dose Receives: Drug: QCZ484 |
| Part B: QCZ484 300 mg | Experimental | Hypertension Cohort: single dose Receives: Drug: QCZ484 |
| Part B: QCZ484 600 mg | Experimental | Hypertension Cohort: single dose Receives: Drug: QCZ484 |
| Part B: QCZ484 Placebo | Placebo comparator | Hypertension Cohort: single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
Overall number of AEs, severity, and relationship to study treatment per treatment group.
Measured: 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)
Measured: Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose
Secondary outcomes (9)
Number of AEs
Overall number of AEs, severity and relationship to study treatment per treatment group
Measured: up to 48 weeks post dose
Number of participants with abnormalities in any laboratory parameter
Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis)
Measured: up to 48 weeks post dose
Plasma pharmacokinetics of QCZ484 and metabolites - Cmax
Measured by Cmax - The maximum plasma concentration of QCZ484 and of potential metabolites
Measured: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 - Tmax
Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of QCZ484
Measured: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48
Measured by AUC - Area under the curve versus time curve of QCZ484 from 0 to 48 hours (AUC0-48) and of potential metabolites
Measured: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 - AUC0-inf
Measured by AUC - Area under the curve versus time curve of QCZ484 from 0 to infinity (AUC0-inf)
Measured: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 - T1/2
Measured by T1/2 - The elimination half-life of QCZ484
Measured: Day 1; up to Day 8
Urine pharmacokinetics of QCZ484
Measured by urine concentration of QCZ484 up to 24 hours post dose
Measured: Day 1; up to Day 2
Change from baseline in serum angiotensinogen (AGT) level
Measured by serum AGT level
Measured: up to 48 weeks post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start8 Mar 2023
- Primary completion25 Sep 2024
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905327
- Sponsor's protocol ID
- CQCZ484A02101
- Other IDs
- BW-00163-1002
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06905327
- Acronym / sponsor ID
- CQCZ484A02101
- Conditions
- Mild Hypertension
- Keywords
- Hypertension, QCZ484
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part A: QCZ484 50 mg | Experimental | Drug: QCZ484Healthy Cohort: single dose |
| Part A: QCZ484 150 mg | Experimental | Drug: QCZ484Healthy Cohort: single dose |
| Part A: QCZ484 300 mg | Experimental | Drug: QCZ484Healthy Cohort: single dose |
| Part A: QCZ484 600 mg | Experimental | Drug: QCZ484Healthy Cohort: single dose |
| Part A: QCZ484 Placebo | Placebo comparator | Drug: PlaceboHealthy Cohort: single dose |
| Part B: QCZ484 150 mg | Experimental | Drug: QCZ484Hypertension Cohort: single dose |
| Part B: QCZ484 300 mg | Experimental | Drug: QCZ484Hypertension Cohort: single dose |
| Part B: QCZ484 600 mg | Experimental | Drug: QCZ484Hypertension Cohort: single dose |
| Part B: QCZ484 Placebo | Placebo comparator | Drug: PlaceboHypertension Cohort: single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QCZ484doses of 50, 150, 300 or 600 mg via subcutaneous injection | Drug | Part A: QCZ484 150 mg, Part A: QCZ484 300 mg, Part A: QCZ484 50 mg, Part A: QCZ484 600 mg, Part B: QCZ484 150 mg, Part B: QCZ484 300 mg, Part B: QCZ484 600 mg |
| Placebovia subcutaneous injection | Drug | Part A: QCZ484 Placebo, Part B: QCZ484 Placebo |
Primary outcome
Number of adverse events (AEs)
Time frame: Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose.
Overall number of AEs, severity, and relationship to study treatment per treatment group.
Number of participants with abnormalities in any laboratory parameter
Time frame: Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose
Safety laboratory data (blood chemistry, hematology, coagulation, and urinalysis)
9 secondary outcomes
Number of AEs
Time frame: up to 48 weeks post dose
Number of participants with abnormalities in any laboratory parameter
Time frame: up to 48 weeks post dose
Plasma pharmacokinetics of QCZ484 and metabolites - Cmax
Time frame: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 - Tmax
Time frame: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48
Time frame: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 - AUC0-inf
Time frame: Day 1; up to Day 8
Plasma pharmacokinetics of QCZ484 - T1/2
Time frame: Day 1; up to Day 8
Urine pharmacokinetics of QCZ484
Time frame: Day 1; up to Day 2
Change from baseline in serum angiotensinogen (AGT) level
Time frame: up to 48 weeks post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QCZ484 in people with Mild Hypertension, run by Novartis Pharmaceuticals at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AEs) (time frame: Part A: up to 12 weeks post dose. Part B: up to 8 weeks post dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.