Safety and Tolerability of STP206 in Healthy Adult Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: STP206 STP206 administered either as a single dose or as a daily dose for seven consecutive days |
Drug: STP206 or vehicle control
STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days
|
| Placebo Comparator: Vehicle Control STP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days |
Drug: STP206 or vehicle control
STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days
|
Outcome Measures
Primary Outcome Measures
- Adverse events [7-days post dosing and 30-days post dosing]
- Changes in physical examination findings [7-days post dosing]
- Changes in laboratory (hematology, chemistry, and urinalysis) variables [7-days post dosing]
Secondary Outcome Measures
- Fecal Shedding of STP206 components [30 days post dosing]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy volunteers, 18 - 55 years of age
-
In general good heath as established by medical history, physical examination, and laboratory assessment
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The subject is willing and able to comply with the protocol and complete all visits and procedures
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Provide written informed consent after the nature of the study has been explained
Exclusion Criteria:
-
Subjects with any chronic illness or conditions that require treatment
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Subjects with clinically significant abnormal laboratory values noted during the screening laboratory evaluation
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Subjects with history of immune compromised conditions or any past use of immunosuppressant treatment
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Subjects with current or past history of gastrointestinal disease, including any conditions with increased risk for bleeding (e.g., gingivitis, hemorrhoids)
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Subjects who are lactose intolerant
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Subjects who are intolerant or allergic to Splenda® or any of its ingredients (dextrose, maltodextrin, sucralose) or have a soy allergy
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Subjects who have had a fever of 100°F or higher within the 2 weeks of the first dose of study drug
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Subjects who have received a "live" vaccine within 30 days of the first dose of study drug
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Subjects who have received any medications (prescription or OTC) within 2 weeks of the first dose of study drug
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Subjects who have received and investigational drug with 30 days prior to the first dose of study drug
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Subjects with a history of illicit drug use or alcohol abuse
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Subjects with any other medical condition that may influence the objectives or outcomes of the study
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Female subjects who are pregnant or lactating
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Female subjects of childbearing potential who are not using an FDA approved birth control method
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Subjects who are healthcare or daycare providers or those with close contact with immune compromised individuals
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SNBL Clinical Pharmacology Center, Inc. | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- Leadiant Biosciences, Inc.
Investigators
- Study Director: Taha Keilani, MD, Leadiant Biosciences, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STP206-001