Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Fucoidan (extract of Laminaria japonica)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAX 513<br>Capsule - one of 5 dose levels (per randomization) - BID (= twice a day) | Other: Fucoidan (extract of Laminaria japonica)<br>* Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID<br>* Other names: BAX 513;|
| Placebo Comparator: Capsule (cellulose)<br>Capsule - one of 5 dose levels (per randomization) - BID | Other: Placebo<br>* Cellulose filled capsule - oral administration - 5 different dose levels - BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak thrombin concentration from baseline as measured by the Thrombin Generation Assay (TGA). |  | 7 months (= anticipated study duration) |