Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361836
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-08
Brief Title:
Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
Sponsor:
Sonoma Biotherapeutics Inc
Organization:
Sonoma Biotherapeutics Inc
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Activity of Single Ascending Doses of SBT777101 in Subjects With Hidradenitis Suppurativa
Status:
RECRUITING
Status Verified Date:
2024-10
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:
Regulate-HS
Brief Summary:
This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa Increasing dose levels will be given after the safety at lower dose levels is shown
Detailed Description:
The study evaluates the safety and effects of a novel regulatory CARTreg cell-based autoimmune and inflammatory disease therapy for the treatment of hidradenitis suppurativa The therapy is an autologous using the patients own cells Treg cell therapy that targets proteins in the inflamed disease-associated tissue with the aim to dampen inflammation and restore balance to the immune system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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