Safety and Tolerability of STP206 in Healthy Adult Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Center Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial to Assess the Safety and Tolerability of Single and Multiple Daily Oral Administration of STP206 Live Biotherapeutic in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: STP206 or vehicle control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STP206<br>STP206 administered either as a single dose or as a daily dose for seven consecutive days | Drug: STP206 or vehicle control<br>* STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days<br>|
| Placebo Comparator: Vehicle Control<br>STP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days | Drug: STP206 or vehicle control<br>* STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Shedding of STP206 components |  | 30 days post dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers