Safety and Tolerability of STP206 in Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

The study will assess the safety, tolerability and fecal shedding of STP206 when given as a single dose and when given as daily doses for one week.

Key facts

Study ID

NCT00922324

Run by

Leadiant Biosciences, Inc.

People needed

24

Starts

2010-03-01

Expected to finish

2010-11-01

Last updated by the study team

2013-05-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy volunteers, 18 - 55 years of age
• In general good heath as established by medical history, physical examination, and laboratory assessment
• The subject is willing and able to comply with the protocol and complete all visits and procedures
• Provide written informed consent after the nature of the study has been explained

You may not qualify if…

• Subjects with any chronic illness or conditions that require treatment
• Subjects with clinically significant abnormal laboratory values noted during the screening laboratory evaluation
• Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment
• Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)
• Subjects who are lactose intolerant
• Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy
• Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug
• Subjects who have received a "live" vaccine within 30 days of the first dose of study drug
• Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug
• Subjects who have received and investigational drug with 30 days prior to the first dose of study drug
• Subjects with a history of illicit drug use or alcohol abuse
• Subjects with any other medical condition that may influence the objectives or outcomes of the study
• Female subjects who are pregnant or lactating
• Female subjects of childbearing potential who are not using an FDA approved birth control method
• Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals
• Subjects with a history of acute hepatitis, HIV infection or known to have positive diagnostic tests for HIV or HBV
• Subjects who have a planned dental appointment from screening through 7 days after last dose of Investigational Product.

Where it is running

• SNBL Clinical Pharmacology Center, Inc. — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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