Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03522935
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2018-02-01
Brief Title:
Subcutaneous Elafin in Healthy Subjects
Sponsor:
Roham T Zamanian
Organization:
Stanford University
Study Overview
Official Title:
Safety and Tolerability of Escalating Doses of Subcutaneous Elafin Tiprelestat Injection in Healthy Normal Subjects
Status:
COMPLETED
Status Verified Date:
2024-08
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:
A multiple-ascending-dose MAD randomized placebo-controlled blinded trial to evaluate the safety tolerability pharmacokinetics and pharmacodynamics of Elafin in healthy adult subjects The purpose of this study is to assess Elafin that is being developed for treatment of PAH Elafin inhibits elastase an enzyme that is increased in pulmonary hypertension and is a major factor in the development of PAH Elafin will be administered subcutaneously daily for 7 days in normal healthy subjects followed over a 28 day time period
Detailed Description:
There will be a total of up to 30 subjects randomly assigned to 5 groups with 6 subjects in each group One subject in each group will be assigned to placebo drug and 5 subjects to active drug Subjects in each group will receive a single daily dose of ElafinPlacebo for total of 7 days There will be ascending doses across groups Groups receiving a higher dose will only do so after the previous group has completed dosing ie 7 days Each subject will be followed over a 28 day time period
An interim trial analysis will occur after completion of the 2nd cohort in order for the research team to review PK and safety data to determine modification if needed of dosing strategy for groups 3-5 The study is also designed to absorb a de-escalation strategy If the protocol requires a lowering of dose from the initial dosing a new group will be assigned a low-dose subcutaneous Elafin regimen
The study will conclude at any dose that produces clinically significant adverse effects and identified as Maximum Tolerated Dose MTD
An interim trial analysis will occur after completion of the 2nd cohort in order for the research team to review PK and safety data to determine modification if needed of dosing strategy for groups 3-5 The study is also designed to absorb a de-escalation strategy If the protocol requires a lowering of dose from the initial dosing a new group will be assigned a low-dose subcutaneous Elafin regimen
The study will conclude at any dose that produces clinically significant adverse effects and identified as Maximum Tolerated Dose MTD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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