Hypertension Clinical Trial
Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension
The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in patients with hypertension.
The clinical study described in this protocol is a Phase 1, two-part, multi-center study evaluating safety, tolerability, PK, and PD of ADX-850. The study consists of two parts: - Randomized, double-blind, placebo-controlled, parallel group, single ascending dose (SAD) in patients with hypertension with up to 4 dose cohorts. For SAD cohorts and planned dosing; and - Open-label, parallel group, single fixed dose of ADX-850 in patients with hypertension. After ADX-850 dosing, patients with elevated blood pressure will additionally receive regular dosing of an ARB as an as-indicated concomitant therapy. ;
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