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Completed

NCT Number: NCT06905327

A Study to Evaluate the Safety of QCZ484 in Healthy and Mild Hypertensive Subjects

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.

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Key information

Conditions

Mild Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Herston, Queensland, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QCZ484

Drug

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

Placebo

Drug

via subcutaneous injection

Primary outcomes

  1. 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.

  2. 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)

Secondary outcomes

  1. Number of AEs

    Time frame: up to 48 weeks post dose

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

  2. Number of participants with abnormalities in any laboratory parameter

    Time frame: up to 48 weeks post dose

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

  3. Plasma pharmacokinetics of QCZ484 and metabolites - Cmax

    Time frame: Day 1; up to Day 8

    Measured by Cmax - The maximum plasma concentration of QCZ484 and of potential metabolites

  4. Plasma pharmacokinetics of QCZ484 - Tmax

    Time frame: Day 1; up to Day 8

    Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of QCZ484

  5. Plasma pharmacokinetics of QCZ484 and metabolites - AUC0-48

    Time frame: Day 1; up to Day 8

    Measured by AUC - Area under the curve versus time curve of QCZ484 from 0 to 48 hours (AUC0-48) and of potential metabolites

  6. Plasma pharmacokinetics of QCZ484 - AUC0-inf

    Time frame: Day 1; up to Day 8

    Measured by AUC - Area under the curve versus time curve of QCZ484 from 0 to infinity (AUC0-inf)

  7. Plasma pharmacokinetics of QCZ484 - T1/2

    Time frame: Day 1; up to Day 8

    Measured by T1/2 - The elimination half-life of QCZ484

  8. Urine pharmacokinetics of QCZ484

    Time frame: Day 1; up to Day 2

    Measured by urine concentration of QCZ484 up to 24 hours post dose

  9. Change from baseline in serum angiotensinogen (AGT) level

    Time frame: up to 48 weeks post dose

    Measured by serum AGT level

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 1, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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