Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876312
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-05-17
Brief Title:
Safety Tolerability PK and PD of ADX-038 in HV and Paroxysmal Nocturnal Hemoglobinuria PNH Patients
Sponsor:
ADARx Pharmaceuticals Inc
Organization:
ADARx Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Randomized Placebo-Controlled Double Blind Single Ascending Dose Study in Healthy Volunteers Followed by Open Label Treatment in Patients With PNH to Evaluate the Safety Tolerability PK and PD of ADX-038
Status:
RECRUITING
Status Verified Date:
2023-11
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:
PNH
Brief Summary:
The first-in-human Phase 1 study described herein will evaluate the safety tolerability pharmacokinetics PK and pharmacodynamics PD of ADX-038 in both healthy volunteers HV and in patients with paroxysmal nocturnal hemoglobinuria PNH
Detailed Description:
The clinical study described in this protocol is a Phase 1 single-center study evaluating safety tolerability PK and PD of ADX-038
The study consists of 2 parts
1 Part A - Randomized double-blind placebo-controlled parallel group single ascending dose SAD in HV with up to 5 dose cohorts
2 Part B - Expansion cohort in participants with paroxysmal nocturnal hemoglobinuria PNH at selected dose from Part A and will be open label
The study consists of 2 parts
1 Part A - Randomized double-blind placebo-controlled parallel group single ascending dose SAD in HV with up to 5 dose cohorts
2 Part B - Expansion cohort in participants with paroxysmal nocturnal hemoglobinuria PNH at selected dose from Part A and will be open label
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