Ignite Creation Date:
2024-05-06 @ 1:43 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04103034
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2019-09-19
Brief Title:
A SADMAD Study of Safety Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers
Sponsor:
Band Therapeutics
Organization:
Band Therapeutics
Study Overview
Official Title:
A SingleMultiple Ascending Dose Phase 1 Study of the Safety Tolerability and Pharmacologic Activity of BT200 in Normal Human Volunteers
Status:
COMPLETED
Status Verified Date:
2023-09
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:
Study BT200-01 is a first in human FIH study in male and female normal human volunteers NHVs that uses an Integrated Protocol Design This Phase 1 study will comprise 4 sub-parts Part A a single ascending dose SAD study Part B a multiple ascending dose MAD study Part C a desmopressin challenge study to explore i whether desmopressin could be used as an antidote andor ii whether desmopressin stimulated vonWillebrand Factor VWF release is overcome with increasing BT200 doses and Part D a relative bioavailability BA study
The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs
The primary objective of this study is to assess the safety and tolerability profile of BT200 in NHVs
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?:
None
Is an FDA AA801 Violation?:
None