Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04506645
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2020-07-28
Brief Title:
Study to Assess the Safety Tolerability and Pharmacokinetics of REGN5381 an NPR1 Agonist in Adult Humans
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Two-Part Single Ascending Dose Study to Assess the Safety Tolerability and Pharmacokinetics of REGN5381 an NPR1 Agonist in Humans
Status:
COMPLETED
Status Verified Date:
2022-12
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 primary objective of the study is to evaluate the safety and tolerability of single intravenous IV doses of REGN5381 in healthy normotensive and otherwise healthy hypertensive adults
The secondary objectives of the study are
To evaluate the effect of single IV doses of REGN5381 on blood pressure BP and heart rate HR in healthy normotensive and otherwise healthy hypertensive adults
To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume SV
To evaluate the pharmacokinetics PK of single IV doses of REGN5381
To evaluate the immunogenicity of single IV doses of REGN5381
The secondary objectives of the study are
To evaluate the effect of single IV doses of REGN5381 on blood pressure BP and heart rate HR in healthy normotensive and otherwise healthy hypertensive adults
To evaluate the effect of single IV doses of REGN5381 on cardiac stroke volume SV
To evaluate the pharmacokinetics PK of single IV doses of REGN5381
To evaluate the immunogenicity of single IV doses of REGN5381
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000940-75 | EUDRACT_NUMBER | None | None |