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A SAD/MAD Study of Safety, Tolerability and Pharmacologic Activity of BT200 in Normal Volunteers

NCT04103034 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-03-18

Study results available
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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

DRUG

BT200

BT200 is a PEGylated synthetic RNA oligonucleotide

DRUG

Desmopressin

Sterile solution for injection

DRUG

Placebo

Sterile saline for injection

Sponsors & Collaborators

  • Band Therapeutics

    lead INDUSTRY

Principal Investigators

  • James C Gilbert, MD · Band Therapeutics

  • Ulla Derhaschnig, MD · Medical University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2020-09-14
Completion
2020-09-14

Countries

  • Austria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103034 on ClinicalTrials.gov