Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-29 @ 4:13 AM
Study NCT ID:
NCT05481333
Status:
COMPLETED
Last Update Posted:
2024-07-24
First Post:
2022-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Learn if REGN7999 is Safe and Well Tolerated, and How it Works in the Body of Healthy Participants
Sponsor:
Regeneron Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7999, a TMPRSS6 Antagonist, in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2024-07
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 ascending intravenous (IV) and subcutaneous (SC) doses of REGN7999 in healthy adult participants.
The secondary objectives of the study are:
* To characterize the drug concentration profile of single doses of IV or SC REGN7999
* To assess the immunogenicity of single ascending SC or IV doses of REGN7999
The secondary objectives of the study are:
* To characterize the drug concentration profile of single doses of IV or SC REGN7999
* To assess the immunogenicity of single ascending SC or IV doses of REGN7999
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-500398-15-00 | OTHER | EUCT Number | View |