NCT06905327

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	QCZ484	doses of 50, 150, 300 or 600 mg via subcutaneous injection
DRUG	Placebo	via subcutaneous injection

Timeline

• Start date: 2023-03-08
• Primary completion: 2024-09-25
• Completion: 2025-07-01
• First posted: 2025-04-01
• Last updated: 2025-12-04

Locations

4 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study