Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

Baxalta

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Other: Fucoidan (extract of Laminaria japonica)

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063101

950901

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Is >= 18 and < 70 years old at the time of screening
Is able to provide signed and dated informed consent
Is a healthy male or female adult
If female and of childbearing potential, subject demonstrates a negative serum pregnancy test, and agrees to employ adequate birth control measures; (e.g., oral contraceptives, barrier method) for the duration of the study
If female and receiving hormone replacement therapy (HRT), subject agrees to abstain from HRT for the duration of the study
Subject's medical history and physical exam are normal
Subject's lab values for complete blood count (CBC) and clinical chemistry are within normal ranges
Is able to comprehend and comply with all aspects of the protocol and signed informed consent

Exclusion criteria

If female, subject is pregnant or lactating at the time of study enrollment
Has participated in another clinical study involving an investigational product (IP) or device within 30 days of screening or is scheduled to participate in another clinical study involving an IP or device during the course of this study
Has a history of drug allergy in general or hypersensitivity to fucoidan containing products/foods or seafoods
Medical and/or family history of thrombophilic tendencies, eg Protein C or S-deficiency, ATIII deficiency, FV Leiden mutation, Prothrombin 20210A mutation, lupus type inhibitor, antiphospholipid antibodies
Medical history or clinical findings of a significant bleeding disorder
Medical history of thrombotic events such as venous thromboembolism (VTE), myocardial infarction (MI), stroke or transient ischemic attack (TIA)
Any other clinically relevant history of disease, eg malabsorption disorders, malignancies
Any clinically significant abnormal laboratory values or abnormal ECG findings that in the opinion of the investigator are considered clinically relevant
Seropositivity for HBs-Ag, HCV, HIV-1 or HIV-2 antibodies
Symptoms of a clinically relevant illness within 3 weeks before screening
A history of, or suspected, drug or alcohol abuse, or subject tests positive on a Drugs of Abuse screen within 1 week of dosing
Intake of IP or related (fucoidan-containing) product within 1 week prior to study enrollment
Any planned surgical or dental procedure during the course of this study
Any recent surgery within 30 days of enrollment
Presence of signs or symptoms consistent with an infection, such as fever, chills, or nausea during screening in this study
Chronic or regular use of aspirin, ibuprofen, coumarin derivatives, antiplatelet drugs, within 1 week before enrollment
Use of concomitant drugs diclofenac or [paracetamol if > 2 g/day] within 1 week before first day of study dosing
Plasmapheresis or platelet donation within 3 weeks of screening and until final visit
Any medical condition that may compromise the ability to give written informed consent or to comply with the study protocol
Subject is a member of the team conducting the study or in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study