Trials / Completed
CompletedNCT04103034
A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers
A Single/Multiple Ascending Dose Phase 1 Study of the Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Human Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- Band Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
- Cerebrovascular Stroke
- Large-Artery Atherosclerosis (Embolus/Thrombosis)
- Intracranial Arteriosclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BT200 | BT200 is a PEGylated synthetic RNA oligonucleotide |
| DRUG | Desmopressin | Sterile solution for injection |
| DRUG | Placebo | Sterile saline for injection |
Timeline
- Start date
- 2019-10-07
- Primary completion
- 2020-09-14
- Completion
- 2020-09-14
- First posted
- 2019-09-25
- Last updated
- 2024-03-18
- Results posted
- 2024-03-18
Locations
1 site across 1 country: Austria
Source: ClinicalTrials.gov record NCT04103034. Inclusion in this directory is not an endorsement.