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

NCT03453060 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2019-10-29

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Aronora, Inc.

    lead INDUSTRY

Principal Investigators

  • Danielle Armas, MD · Celerion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2018-11-25
Completion
2018-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT03453060 on ClinicalTrials.gov