Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304740
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2024-03-03
Brief Title:
Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants
Sponsor:
Inmagene LLC
Organization:
Inmagene LLC
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of a Single Subcutaneous Dose of IMG-007 in Healthy Participants
Status:
COMPLETED
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:
This is a double-blind randomized placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants The study will comprise of a 5-week screening period a 3-day In-patient Period in a clinical research unit CRU and an Out-patient Follow-up Period up to 127 days The study will include 3 dose cohorts which will be enrolled sequentially Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose
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?:
False
Is an FDA AA801 Violation?:
None