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

Novartis

Status and phase: Completed; Phase 1

Conditions: Mild Hypertension

Treatments: Drug: Placebo; Drug: QCZ484

Study type: Interventional

Funder types: Industry

Identifiers

NCT06905327

CQCZ484A02101

BW-00163-1002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

56 participants in 9 patient groups, including a placebo group

Part A: QCZ484 50 mg

Experimental group

Description:

Healthy Cohort: single dose

Treatment:

Drug: QCZ484

Part A: QCZ484 150 mg

Experimental group

Description:

Healthy Cohort: single dose

Treatment:

Drug: QCZ484

Part A: QCZ484 300 mg

Experimental group

Description:

Healthy Cohort: single dose

Treatment:

Drug: QCZ484

Part A: QCZ484 600 mg

Experimental group

Description:

Healthy Cohort: single dose

Treatment:

Drug: QCZ484

Part A: QCZ484 Placebo

Placebo Comparator group

Description:

Healthy Cohort: single dose

Treatment:

Drug: Placebo

Part B: QCZ484 150 mg

Experimental group

Description:

Hypertension Cohort: single dose

Treatment:

Drug: QCZ484

Part B: QCZ484 300 mg

Experimental group

Description:

Hypertension Cohort: single dose

Treatment:

Drug: QCZ484

Part B: QCZ484 600 mg

Experimental group

Description:

Hypertension Cohort: single dose

Treatment:

Drug: QCZ484

Part B: QCZ484 Placebo

Placebo Comparator group

Description:

Hypertension Cohort: single dose

Treatment:

Drug: Placebo