Trial Outcomes & Findings for A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure (NCT NCT02998840)
NCT ID: NCT02998840
Last Updated: 2022-09-15
Results Overview
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Baseline-6 weeks
Results posted on
2022-09-15
Participant Flow
Participant milestones
| Measure |
B244 4 Pumps Applied to the Face
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Vehicle 4 Pumps Applied to the Face
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
Vehicle 8 Pumps Applied to Face and Torso
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
33
|
33
|
|
Overall Study
COMPLETED
|
29
|
30
|
31
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
2
|
5
|
Reasons for withdrawal
| Measure |
B244 4 Pumps Applied to the Face
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Vehicle 4 Pumps Applied to the Face
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
Vehicle 8 Pumps Applied to Face and Torso
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
|
Overall Study
Unplanned travel, family emergency, sponsor request, work schedule
|
2
|
1
|
0
|
1
|
Baseline Characteristics
A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure
Baseline characteristics by cohort
| Measure |
B244 4 Pumps Applied to the Face
n=33 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=33 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Vehicle 4 Pumps Applied to the Face
n=33 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
Vehicle 8 Pumps Applied to Face and Torso
n=33 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<60 years
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
100 Participants
n=31 Participants
|
|
Age, Customized
≥60 years
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
62 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
70 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
38 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
94 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
90 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Weight
|
89.32 kg
STANDARD_DEVIATION 21.084 • n=99 Participants
|
89.04 kg
STANDARD_DEVIATION 21.654 • n=107 Participants
|
86.56 kg
STANDARD_DEVIATION 12.251 • n=206 Participants
|
88.59 kg
STANDARD_DEVIATION 18.871 • n=7 Participants
|
88.38 kg
STANDARD_DEVIATION 18.654 • n=31 Participants
|
|
BMI
|
30.139 kg/m^2
STANDARD_DEVIATION 6.2438 • n=99 Participants
|
30.427 kg/m^2
STANDARD_DEVIATION 5.9047 • n=107 Participants
|
29.306 kg/m^2
STANDARD_DEVIATION 4.3707 • n=206 Participants
|
30.304 kg/m^2
STANDARD_DEVIATION 6.3886 • n=7 Participants
|
30.044 kg/m^2
STANDARD_DEVIATION 5.7332 • n=31 Participants
|
|
BMI Category
<30 kg/m^2
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
77 Participants
n=31 Participants
|
|
BMI Category
≥30 kg/m^2
|
14 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Smoking History
Never
|
19 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
82 Participants
n=31 Participants
|
|
Smoking History
Former
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Smoking History
Current
|
8 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline-6 weeksPopulation: Safety Population: All subjects who received at least 1 dose of study medication. Subjects were to be analyzed according to the study drug received.
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Outcome measures
| Measure |
B244 4 Pumps Applied to the Face
n=33 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=33 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=66 Participants
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
At Least 1 Treatment Related Serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
At Least 1 Treatment Related TEAE
|
1 Participants
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Baseline-Week 4Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4.
Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Outcome measures
| Measure |
B244 4 Pumps Applied to the Face
n=29 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=30 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=61 Participants
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
|
-2.61 mmHg
Standard Deviation 1.828
|
-0.66 mmHg
Standard Deviation 1.834
|
-2.93 mmHg
Standard Deviation 1.296
|
SECONDARY outcome
Timeframe: Baseline-Week 4Population: Subjects from the Intent to Treat (ITT) population (all randomized subjects, analyzed according to treatment assigned) that remained in the study at Week 4.
Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Outcome measures
| Measure |
B244 4 Pumps Applied to the Face
n=29 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=30 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=61 Participants
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
|
-1.65 mmHg
Standard Deviation 1.377
|
-2.25 mmHg
Standard Deviation 1.358
|
-1.31 mmHg
Standard Deviation 0.975
|
SECONDARY outcome
Timeframe: Baseline-Week 4Population: Ambulatory Blood Pressure Monitoring Population (ABPP): Subjects in the Safety Population who had valid baseline and Day 28 ambulatory BP monitoring (ABPM) measurements. Subjects who repeated the ABPM were to be included in the population if the repeated assessment met the device monitor's criteria for "passing".
An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.
Outcome measures
| Measure |
B244 4 Pumps Applied to the Face
n=29 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=29 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=58 Participants
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
Systolic Blood Pressure
|
-3.06 mmHg
Standard Deviation 9.388
|
-0.21 mmHg
Standard Deviation 12.250
|
-0.53 mmHg
Standard Deviation 7.619
|
|
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
Diastolic Blood Pressure
|
-2.17 mmHg
Standard Deviation 5.327
|
-0.82 mmHg
Standard Deviation 7.325
|
-0.98 mmHg
Standard Deviation 5.911
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline-Week 4Population: Intent to Treat Population (ITT): All randomized subjects, analyzed according to treatment assigned.
To evaluate if B244 administration on the skin twice daily will affect the levels of immune biomarkers.
Outcome measures
| Measure |
B244 4 Pumps Applied to the Face
n=33 Participants
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=33 Participants
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=66 Participants
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Difference in Inflammatory Biomarkers Between Active and Vehicle Groups
|
NA units on a scale
Standard Deviation NA
NA Explanation: Data not collected/completed for exploratory endpoint.
|
NA units on a scale
Standard Deviation NA
NA Explanation: Data not collected/completed for exploratory endpoint.
|
NA units on a scale
Standard Deviation NA
NA Explanation: Data not collected/completed for exploratory endpoint.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 28, Day 42Population: Data was not collected for this exploratory endpoint.
Evaluate if B244 administration on skin twice daily will affect the microbial content on collected skin swab samples.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 28, Day 42Population: Data was not collected for this exploratory endpoint.
Evaluate if B244 administration on skin twice daily will affect the microbial composition on collected skin samples.
Outcome measures
Outcome data not reported
Adverse Events
B244 4 Pumps Applied to the Face
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
B 244 8 Pumps Applied to Face and Torso
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
B244 4 Pumps Applied to the Face
n=33 participants at risk
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=33 participants at risk
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=66 participants at risk
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Psychiatric disorders
Exacerbation of depression
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
Other adverse events
| Measure |
B244 4 Pumps Applied to the Face
n=33 participants at risk
4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
B 244 8 Pumps Applied to Face and Torso
n=33 participants at risk
8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks.
B244: odorless suspension, 8x10E9 cells/mL
|
Pooled Vehicle 4 or 8 Pumps Applied to the Face (and Torso for 8 Pumps)
n=66 participants at risk
4 or 8 pumps total of spray to saturate the entire face (and torso for 8 pumps). Applications should occur in the morning and at night for 4 weeks.
Vehicle: odorless suspension
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
2/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
4.5%
3/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Investigations
Glycosylated haemoglobin increased
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Investigations
Weight increased
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
2/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
General disorders
Pyrexia
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
1.5%
1/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
|
Psychiatric disorders
Depression
|
0.00%
0/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
3.0%
1/33 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
0.00%
0/66 • Baseline-Week 6
Participants will report adverse events immediately to the Investigator and study personnel. A safety assessment will be performed at each visit. All adverse events (AEs) recorded during the study through the date of randomization through 28 days after the last dose of study drug will be analyzed.
|
Additional Information
Hyun Kim, Vice President Clinical Operations
AOBiome Therapeutics
Phone: 617-639-9980
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall have 45 days to review the papers. Sponsor shall have the right to require Institution/Principal Investigator, as applicable, to remove specifically identified confidential information and/or delay the proposed publication or presentation for an additional one hundred twenty (120) days to enable Sponsor to seek patent protections.
- Publication restrictions are in place
Restriction type: OTHER