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Safety, Tolerability, PK and PD of ADX-850 in Participants With Hypertension

Hypertension Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ADX-850 in Participants With Hypertension

Clinical Trial Summary

The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ADX-850 in patients with hypertension.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06205628
Study type Interventional
Source ADARx Pharmaceuticals, Inc.
Contact Markus P Schlaich, MD
Phone +61892240382
Email markus.schlaich@uwa.edu.au
Status Recruiting
Phase Phase 1
Start date March 21, 2024
Completion date June 30, 2026
View Details
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