CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
E-WE Thrombin- Dose 1 +4 moredrug
Likely dose
E-WE Thrombin- Dose 1 0.5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03453060
NCT03453060Phase 1Completed
CompareCT.gov

A Phase 1, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of E-WE Thrombin as an Intravenous Bolus in Healthy Adult Subjects

Aronora, Inc.·interventional·Posted Mar 5, 2018·Updated Oct 29, 2019

In Brief

A Phase 1 clinical trial evaluating E-WE Thrombin- Dose 1, E-WE Thrombin- Dose 2, and 3 other interventions for Thrombosis. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMar 5, 2018
Enrollment StartMay 30, 2018
Primary CompletionNov 25, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 8.3 years ago

Interventions

E-WE Thrombin- Dose 1drug

Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.

E-WE Thrombin- Dose 2drug

Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.

E-WE Thrombin- Dose 3drug

Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.

E-WE Thrombin- Dose 4drug

Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.

Placeboother

Participants received a single intravenous dose of placebo.