A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers
Status:
Completed
Trial end date:
2020-09-14
Target enrollment:
Participant gender:
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, and/or (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.