Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT07108894
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Sponsor:
AbCellera Biologics Inc.
Organization:
Study Overview
Official Title:
A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2025-07
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 study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo
Detailed Description:
This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 4 planned cohorts (A1 to A4), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A4.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 297628 | OTHER | Health Canada CTA control number | View |