Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06356259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-04
Brief Title:
A Study to Evaluate the Safety Tolerability and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants
Sponsor:
ImmunoRx Pharma Inc
Organization:
ImmunoRx Pharma Inc
Study Overview
Official Title:
A Randomised Placebo-Controlled Double-blind Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 purpose of the study is to evaluate the safety tolerability and pharmacokinetics with intravenousIV administration of IRX-010 in Healthy Participants
Detailed Description:
This is a single and multiple ascending dose proof of concept study assessing the safe and tolerable dose of IRX-010 in healthy participants Approximately 81 healthy participants will be enrolled in up to 9 cohorts The study is conducted in two parts part A and part B with 6 single ascending dose Part A - SAD cohorts of 9 participants per cohort and 3 multiple ascending dose Part B - MAD cohorts of 9 participants per cohort
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 |
|---|---|---|---|
| 2023-503917-31 | EUDRACT_NUMBER | None | None |