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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2025-07-01

Brief Summary

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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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Detailed Description

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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

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Mild Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: QCZ484 50 mg

Healthy Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part A: QCZ484 150 mg

Healthy Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part A: QCZ484 300 mg

Healthy Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part A: QCZ484 600 mg

Healthy Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part A: QCZ484 Placebo

Healthy Cohort: single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

via subcutaneous injection

Part B: QCZ484 150 mg

Hypertension Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part B: QCZ484 300 mg

Hypertension Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part B: QCZ484 600 mg

Hypertension Cohort: single dose

Group Type EXPERIMENTAL

QCZ484

Intervention Type DRUG

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

Part B: QCZ484 Placebo

Hypertension Cohort: single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

via subcutaneous injection

Interventions

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QCZ484

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

Intervention Type DRUG

Placebo

via subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes