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

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12623000023651

Enrollment

Registered

2023-01-10

Start date

2023-03-28

Completion date

2024-08-01

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a randomized, double-blind, placebo-controlled, single ascending dose study including Part A in healthy subjects and Part B in subjects with mild hypertension. Approximately 68 men and women who fulfill the inclusion and exclusion criteria will be enrolled at one or more sites in Australia and other countries. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2, and return for outpatient visits through Week 48. In Part A, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of QCZ484 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion. Cohorts 1 to 4 will receive QCZ484 doses of 50, 150, 300, and 600mg, or placebo respectively. In Part B, 12 subjects will be randomized in a 2:1 ratio to receive a single dose of QCZ484 (n=8) or placebo (n=4) on Day 1 in a double-blind fashion in each cohort. Cohorts 5 , 6 and 7 will receive single dose of QCZ484 300, 600 mg and 150mg, or placebo respectively.

Interventions

Treatment: Drugs - QCZ484 Part A: 4 Cohorts: 50mg, 150mg, 300mg and 600mg Part B: 3 Cohorts: 150mg, 300mg and 600mg For both Parts: The duration of administration: single dose QCZ484 will be administered via subcutaneous injection by registered nurse. Part A will enroll healthy subjects into 4 separate and sequential dose cohorts. Part B will enroll subjects with mild hypertension into 3 separate cohorts. Part B cohorts will start as follows: - Cohort 5 (300 mg): After dose escalation decision

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 72 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy males or females aged 18 to 60 years, inclusive, at the time of informed consent (Part A only). 2. Males or females aged 18 to 72 years, inclusive, at the time of informed consent (Part B only). 3. Body mass index (BMI) at least 18 and less than or equal to 32 kg/m2 and body weight >50 kg (Part A only) 4. Body mass index (BMI) at least 18 and less than or equal to 35 kg/m2 and body weight >50 kg (Part B only) 5. Triplicate 12-lead electrocardiogram (ECG) after >5 minutes resting without clinically significant findings at screening and Day -1. 6. Mean sitting SBP of >= 130 and <160 mmHg (Part B only)

Exclusion criteria

1. History of hypotension or orthostatic hypotension. 2. History of syncope. 3. SBP <90 mmHg or DBP <60 mm Hg at screening (Part A only). 4. Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening. 5. History or presence of type 1 or type 2 diabetes mellitus at screening (Fasting blood glucose >7.0 mmol/L or HBA1c >6.5%). 6. Any liver function panel analyte value > 1.2 ×upper limits of normal (ULN) at screening.

Outcome results