NCT03453060

Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aronora, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	E-WE Thrombin- Dose 1	Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
DRUG	E-WE Thrombin- Dose 2	Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
DRUG	E-WE Thrombin- Dose 3	Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
DRUG	E-WE Thrombin- Dose 4	Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
OTHER	Placebo	Participants received a single intravenous dose of placebo.

Timeline

• Start date: 2018-05-30
• Primary completion: 2018-11-25
• Completion: 2018-11-25
• First posted: 2018-03-05
• Last updated: 2019-10-29
• Results posted: 2019-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study