Autistic Disorder
Conditions
Keywords
Lactobacillus reuteri, autistic disorder, microbiome
Brief summary
SB-121 is being developed for use in the treatment of autistic disorder (AD). This study is a multiple-dose, randomized, double-blind, placebo-controlled, cross-over single-site Phase I study. The primary objective is to evaluate the safety and tolerability of multiple doses of SB-121 in subjects ages 15 to 45 years with AD. Additionally, multiple measures of AD, as well as mechanistic biomarkers, will be assessed in order to inform later stage trials.
Interventions
DRUGSB-121
SB-121 is a formulation of L. reuteri
DRUGPlacebo
Placebo oral formulation
Sponsors
Scioto Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Subject/parent (or authorized designee) has provided written informed consent for the study. * Subject is ≥15 and ≤45 years of age at the time of enrollment. * Diagnosis of autistic disorder (AD) as confirmed by the gold standard clinical interview using Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and administration of the Autism Diagnostic Observation Schedule-2. * Subject, if female and of childbearing potential, is not lactating or pregnant. * Subject, if female, is either not of childbearing potential or is practicing an acceptable effective method of birth control. * Subject is willing to comply with all study requirements (including the requirements for stool sampling and biobanking) and to return to the study facility for the follow-up evaluations, as required.
Exclusion criteria
* Subject has known allergy or significant adverse reaction to L reuteri, Sephadex®, maltose, or related compounds. * Subject has previously had GI surgery, intestinal obstruction, Clostridium difficile infection or diverticulitis. * Subject has travelled outside of the USA in the 30 days prior to screening. * Subject has had a diarrheal illness in 30 days prior to screening. * Subject currently has a fever or active/uncontrolled gastrointestinal (GI) symptoms (e.g., nausea, vomiting, diarrhea, constipation, abdominal distention, abdominal pain/cramps, flatulence) or has had these within 14 days prior to screening. If the GI symptoms are stable, in the opinion of the investigator, the subject can be enrolled. * Subject has any immunological/autoimmune disorder including, but not limited to, systemic lupus erythematosis, rheumatoid arthritis, Sjögren's syndrome, inflammatory bowel disease, or immunoglobulin-deficiency disorder, that would increase the risk to the subject or interfere with the evaluation of SB-121. * Subject has a documented history of human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C * Subject has implanted prosthetic devices including prosthetic heart valves. * Subject has taken, or is taking, any of the following prohibited medications: 1. A proton pump inhibitor within 2 weeks prior to screening 2. Use of supplemental probiotics within 2 weeks prior to screening except for yogurt 3. Current use of immunosuppressive medications, including corticosteroids 4. Treatment with monoclonal antibodies within 4 weeks prior to screening 5. Systemic antibiotics within 2 weeks prior to screening * Subject has diabetes mellitus or is prediabetic. * Subject has received any IP (or investigational device) within 30 days prior to screening. * Subject has any of the following laboratory test results at Screening: 1. An absolute neutrophil count of \<1.5 × 10\^9/L 2. alanine aminotransferase or aspartate aminotransferase \>1.5 × upper limit normal (ULN), total bilirubin \>1.5 × ULN (subjects with known Gilbert's Syndrome can be included) 3. serum creatinine \>1.5 × ULN 4. any other abnormal laboratory test that is clinically significant in the judgment of the investigator. * Subject has an unstable medical condition or is otherwise considered unreliable or incapable, in the opinion of the investigator, of complying with the requirements of the protocol. * Subject tests positive for drugs of abuse in a urine drug screen at screening. * Subject has a history of alcohol abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Approximately 98 days | Adverse event of special interest (AESIs) and adverse events (AEs) leading to discontinuation from the study are presented. Treatment Period 1: 2 participants reported 4 events in the SB-121 group and 3 participant reported 6 events in the placebo group. Treatment Period 2: 1 participant reported 3 events in the SB-121 group and 1 participant reported 4 events in the placebo group. |
| Sephadex Microspheres in the Stool | Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 42 (period = 28 days and 14 days wash-out) | The presence of Sephadex microspheres in the stool was assessed. The number of participants with data available at each stage are presented. |
| Symptomatic Bacteremia With Positive L. Reuteri Identification | Approximately 98 days | The presence of symptomatic bacteremia with positive L. reuteri identification was assessed and none of the participants in either group showed any clinical features of suspected bacteremia in this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out) | Mean (standard deviation) percent change from baseline in stool biomarkers, fecal lactoferrin. The number of participants with data available are presented. |
| Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α | Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out) | Mean (standard deviation) percent changes from baseline in tumor necrosis factor-α |
| Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin | Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out) | Mean (standard deviation) percent changes from baseline in plasma vasopressin levels |
| Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin | Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 and 28 (period = 28 days and 14 days wash-out) | The mean (standard deviation) percent changes from baseline in plasma oxytocin. |
| Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP) | Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out) | Mean (standard deviation) percent change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) |
| Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out) | Mean (standard deviation) percent change from baseline in stool biomarkers, fecal calprotectin. The number of participants with data available are presented. |
Countries
United States
Participant flow
Pre-assignment details
A total of 15 participants were randomized in this crossover study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (SB-121 - Placebo) Treatment Period 1: One oral dose of SB-121 daily for 28 days. Treatment Period 2: One oral dose of placebo daily for 28 days. SB-121: SB-121 is a formulation of L. reuteri | 7 |
| Group 2 (Placebo - SB-121) Treatment Period 1: One dose of oral placebo daily for 28 days. Treatment Period 2: One oral dose of SB-121 daily for 28 days. SB-121: SB-121 is a formulation of L. reuteri | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Group 2 (Placebo - SB-121) | Total | Group 1 (SB-121 - Placebo) |
|---|---|---|---|
| Age, Continuous | 19.9 years STANDARD_DEVIATION 4.09 | 20.0 years STANDARD_DEVIATION 3.05 | 20.1 years STANDARD_DEVIATION 1.46 |
| Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2) Score | 13.6 ADOS-2 Score STANDARD_DEVIATION 3.02 | 14.7 ADOS-2 Score STANDARD_DEVIATION 3.79 | 16.0 ADOS-2 Score STANDARD_DEVIATION 4.4 |
| Body mass index | 31.29 kilogram/meter squared STANDARD_DEVIATION 14.552 | 27.01 kilogram/meter squared STANDARD_DEVIATION 11.606 | 22.11 kilogram/meter squared STANDARD_DEVIATION 3.859 |
| Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5 checklist) Met criteria for Autism Spectrum Disorder | 8 Participants | 15 Participants | 7 Participants |
| Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5 checklist) Not met criteria for Autism Spectrum Disorder | 0 Participants | 0 Participants | 0 Participants |
| Drug Abuse Screen via Urine Negative | 6 Participants | 12 Participants | 6 Participants |
| Drug Abuse Screen via Urine Positive | 2 Participants | 3 Participants | 1 Participants |
| Height | 178.54 centimeters STANDARD_DEVIATION 6.28 | 178.27 centimeters STANDARD_DEVIATION 6.343 | 177.96 centimeters STANDARD_DEVIATION 6.904 |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 8 Participants | 15 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment United States | 8 participants | 15 participants | 7 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
| Weight | 98.26 kilograms STANDARD_DEVIATION 40.006 | 84.92 kilograms STANDARD_DEVIATION 32.538 | 69.67 kilograms STANDARD_DEVIATION 9.725 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 7 / 15 | 9 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation
Adverse event of special interest (AESIs) and adverse events (AEs) leading to discontinuation from the study are presented. Treatment Period 1: 2 participants reported 4 events in the SB-121 group and 3 participant reported 6 events in the placebo group. Treatment Period 2: 1 participant reported 3 events in the SB-121 group and 1 participant reported 4 events in the placebo group.
Time frame: Approximately 98 days
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Adverse events leading to discontinuation | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Diarrhoea (AESI) | 1 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Abdominal pain (AESI) | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Abdominal pain upper (AESI) | 2 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Nausea (AESI) | 1 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Vomiting (AESI) | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Adverse events leading to discontinuation | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Diarrhoea (AESI) | 3 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Abdominal pain (AESI) | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Abdominal pain upper (AESI) | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Nausea (AESI) | 0 adverse events |
| SB-121 | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Vomiting (AESI) | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Nausea (AESI) | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Adverse events leading to discontinuation | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Adverse events leading to discontinuation | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Diarrhoea (AESI) | 2 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Abdominal pain upper (AESI) | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Abdominal pain (AESI) | 2 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Diarrhoea (AESI) | 3 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Abdominal pain upper (AESI) | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Vomiting (AESI) | 1 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Nausea (AESI) | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 2 : Abdominal pain (AESI) | 0 adverse events |
| Placebo | Adverse Event of Special Interest (AESIs) and Adverse Events (AEs) Leading to Discontinuation | Treatment Period 1 : Vomiting (AESI) | 2 adverse events |
Primary
Sephadex Microspheres in the Stool
The presence of Sephadex microspheres in the stool was assessed. The number of participants with data available at each stage are presented.
Time frame: Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 42 (period = 28 days and 14 days wash-out)
Population: Intent-to-Treat Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SB-121 | Sephadex Microspheres in the Stool | Period 1 Day 1 | Sephadex Positive | 2 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 1 Day 1 | Sephadex Negative | 1 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 1 Day 28 | Sephadex Positive | 6 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 1 Day 28 | Sephadex Negative | 0 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 1 Day 35/Washout | Sephadex Positive | 2 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 1 Day 35/Washout | Sephadex Negative | 1 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 2 Day 28/End of treatment | Sephadex Positive | 4 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 2 Day 28/End of treatment | Sephadex Negative | 0 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 2 Day 42/Poststudy Washout | Sephadex Positive | 0 Participants |
| SB-121 | Sephadex Microspheres in the Stool | Period 2 Day 42/Poststudy Washout | Sephadex Negative | 3 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 2 Day 28/End of treatment | Sephadex Negative | 0 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 1 Day 1 | Sephadex Positive | 1 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 1 Day 35/Washout | Sephadex Negative | 2 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 1 Day 1 | Sephadex Negative | 2 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 2 Day 42/Poststudy Washout | Sephadex Negative | 2 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 1 Day 28 | Sephadex Positive | 5 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 2 Day 28/End of treatment | Sephadex Positive | 1 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 1 Day 28 | Sephadex Negative | 0 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 2 Day 42/Poststudy Washout | Sephadex Positive | 1 Participants |
| Placebo | Sephadex Microspheres in the Stool | Period 1 Day 35/Washout | Sephadex Positive | 2 Participants |
Primary
Symptomatic Bacteremia With Positive L. Reuteri Identification
The presence of symptomatic bacteremia with positive L. reuteri identification was assessed and none of the participants in either group showed any clinical features of suspected bacteremia in this study.
Time frame: Approximately 98 days
Population: Intent-to-Treat Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB-121 | Symptomatic Bacteremia With Positive L. Reuteri Identification | 0 Participants |
| Placebo | Symptomatic Bacteremia With Positive L. Reuteri Identification | 0 Participants |
Secondary
Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin
The mean (standard deviation) percent changes from baseline in plasma oxytocin.
Time frame: Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 and 28 (period = 28 days and 14 days wash-out)
Population: Safety Population~To be noted changes at crossover in N:~Treatment Period 1 - SB-121 (N=7) and Placebo (N=8) Treatment Period 2 - SB-121 (N=8) and Placebo (N=7)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin | change from baseline to Treatment Period 1 (Day 28) | 178.83 percent | Standard Deviation 167.54 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin | change from baseline to Treatment Period 2 (Day 28/end of treatment) | 44.43 percent | Standard Deviation 118.64 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin | change from baseline to Treatment Period 1 (Day 28) | 61.69 percent | Standard Deviation 95.04 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Plasma Oxytocin | change from baseline to Treatment Period 2 (Day 28/end of treatment) | -18.53 percent | Standard Deviation 26.92 |
Secondary
Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin
Mean (standard deviation) percent changes from baseline in plasma vasopressin levels
Time frame: Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out)
Population: Safety Population~To be noted changes at crossover in N:~Treatment Period 1 - SB-121 (N=7) and Placebo (N=8) Treatment Period 2 - SB-121 (N=8) and Placebo (N=7)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin | change from baseline to Treatment Period 1 (Day 28) | 55.98 percent | Standard Deviation 115.43 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin | change from baseline to Treatment Period 2 (Day 28/end of treatment) | -10.14 percent | Standard Deviation 27.8 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin | change from baseline to Treatment Period 1 (Day 28) | 16.53 percent | Standard Deviation 41.7 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Plasma Vasopressin | change from baseline to Treatment Period 2 (Day 28/end of treatment) | 21.36 percent | Standard Deviation 72.46 |
Secondary
Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP)
Mean (standard deviation) percent change from baseline in serum high-sensitivity C-reactive protein (hs-CRP)
Time frame: Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out)
Population: Safety Population.~To be noted changes at crossover in N:~Treatment Period 1 - SB-121 (N=7) and Placebo (N=8) Treatment Period 2 - SB-121 (N=8) and Placebo (N=7)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP) | changes from baseline to Treatment Period 1 (Day 28) | 173.38 percent | Standard Deviation 306.88 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP) | changes from baseline to Treatment Period 2 (Day 28/end of treatment) | -13.91 percent | Standard Deviation 40.56 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP) | changes from baseline to Treatment Period 1 (Day 28) | 45.70 percent | Standard Deviation 118.29 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Serum High-sensitivity C-reactive Protein (Hs-CRP) | changes from baseline to Treatment Period 2 (Day 28/end of treatment) | -33.13 percent | Standard Deviation 30.52 |
Secondary
Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin
Mean (standard deviation) percent change from baseline in stool biomarkers, fecal calprotectin. The number of participants with data available are presented.
Time frame: Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out)
Population: Safety Population.~To be noted changes at crossover in N:~Treatment Period 1 - SB-121 (N=7) and Placebo (N=8) Treatment Period 2 - SB-121 (N=8) and Placebo (N=7)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | changes from baseline to Treatment Period 1 (Day 28) | 76.1 percent | Standard Deviation 99.79 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | changes from baseline Treatment Period 2 (Day 28/end of treatment) | -39.9 percent | Standard Deviation 25.21 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | changes from baseline Treatment Period 2 (Day 42/poststudy washout) | -4.2 percent | Standard Deviation 35.56 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | changes from baseline to Treatment Period 1 (Day 28) | 2.7 percent | Standard Deviation 67.29 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | changes from baseline Treatment Period 2 (Day 28/end of treatment) | -26.1 percent | Standard Deviation 21.78 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Calprotectin | changes from baseline Treatment Period 2 (Day 42/poststudy washout) | -14.0 percent | Standard Deviation 25.43 |
Secondary
Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin
Mean (standard deviation) percent change from baseline in stool biomarkers, fecal lactoferrin. The number of participants with data available are presented.
Time frame: Period 1: Days 1 (pre-dose), 28 and 35; Period 2: Days 28 and 35 (period = 28 days and 14 days wash-out)
Population: Safety Population.~To be noted changes at crossover in N:~Treatment Period 1 - SB-121 (N=7) and Placebo (N=8) Treatment Period 2 - SB-121 (N=8) and Placebo (N=7)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | change from baseline to Treatment Period 1 (Day 28) | NA percent | — |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | change from baseline to Treatment Period 2 (Day 28/end of treatment) | 12.33 percent | Standard Deviation 36.63 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | change from baseline to Treatment Period 2 (Day 42/poststudy washout) | 47.08 percent | Standard Deviation 105.57 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | change from baseline to Treatment Period 1 (Day 28) | 49.40 percent | Standard Deviation 110.46 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | change from baseline to Treatment Period 2 (Day 28/end of treatment) | -42.90 percent | Standard Deviation 35.75 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Stool Biomarkers, Fecal Lactoferrin | change from baseline to Treatment Period 2 (Day 42/poststudy washout) | -40.97 percent | Standard Deviation 34.52 |
Secondary
Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α
Mean (standard deviation) percent changes from baseline in tumor necrosis factor-α
Time frame: Day -28 to Day 0, Period 1: Day 28; Period 2: Days 1 (pre-dose) and 28 (period = 28 days and 14 days wash-out)
Population: Safety Population.~To be noted changes at crossover in N:~Treatment Period 1 - SB-121 (N=7) and Placebo (N=8) Treatment Period 2 - SB-121 (N=8) and Placebo (N=7)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α | changes from baseline to Treatment Period 1 (Day 28) | 37.98 percentage | Standard Deviation 57.7 |
| SB-121 | Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α | changes from baseline to Treatment Period 2 (Day 28/end of treatment) | -1.11 percentage | Standard Deviation 16.51 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α | changes from baseline to Treatment Period 1 (Day 28) | 0.27 percentage | Standard Deviation 23.23 |
| Placebo | Mean Percent Change From Baseline in Biomarkers: Tumor Necrosis Factor-α | changes from baseline to Treatment Period 2 (Day 28/end of treatment) | 8.77 percentage | Standard Deviation 50.41 |