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

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.

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.

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.