Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205628
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-01-04
Brief Title:
Safety Tolerability PK and PD of ADX-850 in Participants With Hypertension
Sponsor:
ADARx Pharmaceuticals Inc
Organization:
ADARx Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of ADX-850 in Participants With Hypertension
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None