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

ARGO BIOPHARMA AUSTRALIA PTY LTD0 个研究点目标入组 48 人开始时间: 2022年11月8日最近更新: 2023年1月9日

适应症

试验速览

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•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.

•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.

发起方