Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT05670704
Status:
COMPLETED
Last Update Posted:
2024-08-23
First Post:
2022-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
Sponsor:
argenx
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
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:
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy participants. The study IMPs are ARGX-119 or placebo for IV or SC administration.
This study will include 2 parts:
* In part A, ARGX-119 IV (or placebo IV) will be administered to 9 cohorts as single doses , while ARGX-119 SC (or placebo SC) will be administered to a 10th cohort.
* In part B, 4 once-weekly IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.
This study will include 2 parts:
* In part A, ARGX-119 IV (or placebo IV) will be administered to 9 cohorts as single doses , while ARGX-119 SC (or placebo SC) will be administered to a 10th cohort.
* In part B, 4 once-weekly IV doses of ARGX-119 (or placebo IV) will be administered in up to 5 cohorts.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-002529-90 | EUDRACT_NUMBER | None | View |