A Study to Evaluate BW-00163 in Subjects with Hypertension

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-00163 in Subjects with Hypertension

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622001430729

Enrollment

Registered

2022-11-08

Start date

2023-01-23

Completion date

Unknown

Last updated

2024-11-18

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. Approximately 48 men and women aged 18 to 70 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Week 24. The single ascending dose study includes 4 cohorts (50mg, 150mg, 300mg and 600mg) of subjects with mild to moderate hypertension (N = 12 per dose cohort).

Interventions

Treatment: Drugs - BW-00163 4 Cohorts: 50mg, 150mg, 300mg and 600mg The duration of administration: single dose BW-00163 will be administered via subcutaneous injection by registered nurse The used and/or partially used vials can be disposed of per local practice. If the used and/or partially used vials cannot be disposed of at site, they will be returned, along with the unused vials, to the sponsor or its agent after receipt of written authorization from Sponsor.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Has mild to moderate hypertension with mean sitting systolic blood pressure of > = 140 and < = 160 mmHg without hypertensive medication(s) or after 2-week wash-out of antihypertensive medications. 2. 24-hour Ambulatory blood pressure monitoring mean systolic blood pressure > = 130 mmHg. 3. On a usual diet and salt intake for at least 4 weeks prior to screening with no plans to significantly alter diet or weight over course of study.

Exclusion criteria

1. Any uncontrolled or serious disease or clinically significant abnormality in laboratory parameters which in the judgment of the Investigator might compromise the safety of the subject or integrity of the study, interfere with the subject participation in the trial or compromise the trial objectives 2. History of secondary hypertension including, but not limited to any of the following: renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced hypertension 3. History of hypotension or orthostatic hypotension 4. Unstable/underlying known cardiovascular disease 5. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening 6. History or presence of Type 1 or Type 2 diabetes mellitus at screening.

Outcome results