Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-27 @ 8:39 PM
Study NCT ID:
NCT04390568
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2020-05-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial in Healthy Chinese Volunteers to Test How Different Doses of BI 655130 Are Taken up in the Body
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
An Open-label Phase I Trial to Assess Pharmacokinetics and Safety of Single Subcutaneous Doses and Single Intravenous Doses of BI 655130 in Healthy Chinese Male and Female Subjects (Single Doses, Open-label Study in Parallel-group Design).
Status:
COMPLETED
Status Verified Date:
2022-09
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:
The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.
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?:
None
Is an FDA AA801 Violation?: