Single Dose Pharmacokinetics of Oral Dextran Sulfate (UA001) and Intravenous Dextran Sulfate in Healthy Volunteers

Exclusion Criteria

Co-existing Condition:

Volunteers with any of the following are excluded:

• Disorders of coagulation or disorders of plasma lipids.
• Allergy to dextran sulfate, other sulfates, other dextrans.

Concurrent Medication:

Excluded:

• Volunteers who anticipate need for medication during study.

Volunteers with any of the following are excluded:

• Disorders of coagulation or disorders of plasma lipids.
• Allergy to dextran sulfate, other sulfates, other dextrans.

Prior Medication:

Excluded within 2 weeks of study entry:

• Any medication.

Risk Behavior:

Excluded:

• Ingestion of alcohol within 48 hours prior to study.
• History of recent drug or alcohol abuse.
• Disorders of coagulation or disorders of plasma lipids.
• Allergy to dextran sulfate, other sulfates, other dextrans.

Volunteers selected are:

• In good general health as determined by screening history, physical examination, and laboratory panel within established limits of normal for hospital laboratory.
• Consenting volunteers.
• Available for 6 days of continuous hospitalization.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety