Safety and Tolerability of STP206 in Healthy Adult Subjects

NCT ID: NCT00922324

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: QUADRUPLE

Study Groups

STP206

STP206 administered either as a single dose or as a daily dose for seven consecutive days

Group Type: EXPERIMENTAL

STP206 or vehicle control

Intervention Type: DRUG

STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days

Vehicle Control

STP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days

Group Type: PLACEBO_COMPARATOR

STP206 or vehicle control

Intervention Type: DRUG

STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days

Interventions

STP206 or vehicle control

STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy volunteers, 18 - 55 years of age

2. In general good heath as established by medical history, physical examination, and laboratory assessment

3. The subject is willing and able to comply with the protocol and complete all visits and procedures

4. Provide written informed consent after the nature of the study has been explained

Exclusion Criteria

1. Subjects with any chronic illness or conditions that require treatment

2. Subjects with clinically significant abnormal laboratory values noted during the screening laboratory evaluation

3. Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment

4. Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)

5. Subjects who are lactose intolerant

6. Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy

7. Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug

8. Subjects who have received a "live" vaccine within 30 days of the first dose of study drug

9. Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug

10. Subjects who have received and investigational drug with 30 days prior to the first dose of study drug

11. Subjects with a history of illicit drug use or alcohol abuse

12. Subjects with any other medical condition that may influence the objectives or outcomes of the study

13. Female subjects who are pregnant or lactating

14. Female subjects of childbearing potential who are not using an FDA approved birth control method

15. Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals

16. Subjects with a history of acute hepatitis, HIV infection or known to have positive diagnostic tests for HIV or HBV

17. Subjects who have a planned dental appointment from screening through 7 days after last dose of Investigational Product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leadiant Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taha Keilani, MD

Role: STUDY_DIRECTOR

Leadiant Biosciences, Inc.

Locations

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

STP206-001

Identifier Type: -

Identifier Source: org_study_id