Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-20 @ 3:54 PM
Study NCT ID:
NCT02955459
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2016-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
Sponsor:
Venatorx Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2017-07
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:
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DMID 16-0014 | OTHER | DMID | View | |
| 272201300019C-3-0-1 | NIH | None | https://reporter.nih.gov/quic… | View |