Safety and Tolerability of STP206 in Healthy Adult Subjects

NCT00922324 | Completed Phase 1

• 1 other identifier: STP206-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Fecal Shedding of STP206 components

  30 days post dosing

Study Arms (2)

STP206

EXPERIMENTAL

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

Drug: STP206 or vehicle control

Vehicle Control

PLACEBO COMPARATOR

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

Drug: STP206 or vehicle control

Interventions

STP206 or vehicle control DRUG

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

STP206; Vehicle Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Leadiant Biosciences, Inc.: lead

Study Sites (1)

SNBL Clinical Pharmacology Center, Inc.

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Taha Keilani, MD

  Leadiant Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 17, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 17, 2013

Record last verified: 2011-05

Locations

US (1)