Status:
COMPLETED
Safety and Tolerability of STP206 in Healthy Adult Subjects
Lead Sponsor:
Leadiant Biosciences, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00922324
Start Date
March 1 2010
End Date
November 1 2010
Last Update
May 17 2013
Active Locations (1)
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1
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, United States, 21201