Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06555328
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Evaluate Safety and Pharmacokinetics of INF904 in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2a Open-Label Basket Study to Evaluate Safety and Pharmacokinetics of INF904 an Oral C5aR1 Inhibitor in Subjects With Moderate to Severe Chronic Spontaneous Urticaria or Hidradenitis Suppurativa
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study duration for an individual subject includes screening 14 days the treatment period 28 days and the observational follow-up period of 28 days in total 70 days 6 days All subjects will receive IMP for 28 days followed by one End of Study EOS visit 4 weeks after EOT visit
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None