NCT01063101

Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

A Phase 1 Study to Evaluate the Effects of BAX 513 on Hemostatic Parameters in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to investigate whether orally administered BAX 513 (different doses administered for 5 days) affects hemostatic parameters in healthy volunteers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
OTHER	Fucoidan (extract of Laminaria japonica)	Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID
OTHER	Placebo	Cellulose filled capsule - oral administration - 5 different dose levels - BID

Timeline

• Start date: 2010-01-29
• Primary completion: 2010-07-22
• Completion: 2010-08-01
• First posted: 2010-02-05
• Last updated: 2021-05-05

Locations

1 site across 1 country: Austria