HealthyPhase 1NCT00922324
Safety and Tolerability of STP206 in Healthy Adult Subjects
A Phase 1 study of Healthy, run by Leadiant Biosciences, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
SNBL Clinical Pharmacology Center, Inc.
Baltimore, Maryland, 21201
About this study
Official title: 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
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
- Being tested
- STP206 or vehicle control
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP206 or vehicle controlDrug
STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| STP206 | Experimental | STP206 administered either as a single dose or as a daily dose for seven consecutive days Receives: 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 Receives: Drug: STP206 or vehicle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 7-days post dosing and 30-days post dosing
Changes in physical examination findings
Measured: 7-days post dosing
Changes in laboratory (hematology, chemistry, and urinalysis) variables
Measured: 7-days post dosing
Secondary outcomes (1)
Fecal Shedding of STP206 components
Measured: 30 days post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leadiant Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taha Keilani, MD, Study director, Leadiant Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922324
- Sponsor's protocol ID
- STP206-001
- Status last verified
- May 2011
- First submitted
- 15 Jun 2009
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00922324
- Acronym / sponsor ID
- STP206-001
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Leadiant Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STP206 | Experimental | Drug: STP206 or vehicle controlSTP206 administered either as a single dose or as a daily dose for seven consecutive days |
| Vehicle Control | Placebo comparator | Drug: STP206 or vehicle controlSTP206 vehicle administered as either a single dose or as a daily dose for 7 consecutive days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STP206 or vehicle controlSTP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days | Drug | STP206, Vehicle Control |
Primary outcome
Adverse events
Time frame: 7-days post dosing and 30-days post dosing
Changes in physical examination findings
Time frame: 7-days post dosing
Changes in laboratory (hematology, chemistry, and urinalysis) variables
Time frame: 7-days post dosing
1 secondary outcome
Fecal Shedding of STP206 components
Time frame: 30 days post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taha Keilani, MD study director
Leadiant Biosciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Leadiant Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 7-days post dosing and 30-days post dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.