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

Sponsor
Novartis Pharmaceuticals
Study ID
NCT06905327
Phase
PHASE1
Status
Completed

Conditions

  • Mild Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • QCZ484 — DRUG
    doses of 50, 150, 300 or 600 mg via subcutaneous injection
  • Placebo — DRUG
    via subcutaneous injection

Study Details

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.

Key Dates

Start date
Mar 8, 2023
Status verified
Nov 2025
Primary completion
Sep 25, 2024
Completion
Jul 1, 2025

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

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. ]