Trial Outcomes & Findings for Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis (NCT NCT03290248)

NCT ID: NCT03290248

Last Updated: 2022-11-25

Results Overview

Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 71 participants
• Primary outcome timeframe: Baseline to Day 28
• Results posted on: 2022-11-25

Participant Flow

Participant milestones

Measure	Vehicle Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Study Part 1 STARTED	8	8	8
Study Part 1 COMPLETED	8	8	8
Study Part 1 NOT COMPLETED	0	0	0
Study Part 2 STARTED	15	16	16
Study Part 2 COMPLETED	15	16	16
Study Part 2 NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.

Baseline characteristics by cohort

Measure	Vehicle n=23 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=24 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=24 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle	Total n=71 Participants Total of all reporting groups
Age, Continuous Part 1	47.29 years STANDARD_DEVIATION 11.179 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	44.60 years STANDARD_DEVIATION 11.193 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	45.36 years STANDARD_DEVIATION 10.316 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	45.76 years STANDARD_DEVIATION 10.477 • n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Age, Continuous Part 2	47.20 years STANDARD_DEVIATION 9.470 • n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	45.49 years STANDARD_DEVIATION 12.145 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	42.30 years STANDARD_DEVIATION 12.754 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	44.95 years STANDARD_DEVIATION 11.516 • n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Sex: Female, Male Part 1 · Female	3 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	11 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Sex: Female, Male Part 1 · Male	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	13 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Sex: Female, Male Part 2 · Female	10 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	12 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	9 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	31 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Sex: Female, Male Part 2 · Male	5 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	4 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	7 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	16 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Ethnicity (NIH/OMB) Part 1 · Hispanic or Latino	3 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	13 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Ethnicity (NIH/OMB) Part 1 · Not Hispanic or Latino	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	2 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	1 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	8 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Ethnicity (NIH/OMB) Part 1 · Unknown or Not Reported	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	1 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	2 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Ethnicity (NIH/OMB) Part 2 · Hispanic or Latino	3 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	1 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	7 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Ethnicity (NIH/OMB) Part 2 · Not Hispanic or Latino	12 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	15 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	13 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	40 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Ethnicity (NIH/OMB) Part 2 · Unknown or Not Reported	0 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · American Indian or Alaska Native	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · Asian	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	1 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	2 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · Black or African American	2 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	2 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	1 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · White	6 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	16 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · More than one race	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 1 · Unknown or Not Reported	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · American Indian or Alaska Native	1 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	1 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · Asian	3 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	2 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	6 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	11 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · Black or African American	5 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	9 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	19 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · White	6 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	16 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · More than one race	0 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Race (NIH/OMB) Part 2 · Unknown or Not Reported	0 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Tobacco History Part 1 · Never	8 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	8 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	5 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	21 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Tobacco History Part 1 · Current	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Tobacco History Part 1 · Former	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Tobacco History Part 2 · Never	12 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	16 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	16 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	44 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Tobacco History Part 2 · Current	0 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Tobacco History Part 2 · Former	3 Participants n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	0 Participants n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	3 Participants n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Screening Height Part 1	174.0 cm STANDARD_DEVIATION 8.20 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	169.8 cm STANDARD_DEVIATION 8.40 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	172.8 cm STANDARD_DEVIATION 11.60 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	172.2 cm STANDARD_DEVIATION 9.24 • n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Screening Height Part 2	169.0 cm STANDARD_DEVIATION 3.73 • n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	165.9 cm STANDARD_DEVIATION 8.38 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	167.1 cm STANDARD_DEVIATION 9.88 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	167.3 cm STANDARD_DEVIATION 8.39 • n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Screening Weight Part 1	81.83 kg STANDARD_DEVIATION 22.316 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	77.94 kg STANDARD_DEVIATION 10.679 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	89.55 kg STANDARD_DEVIATION 21.376 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	83.10 kg STANDARD_DEVIATION 18.699 • n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Screening Weight Part 2	76.89 kg STANDARD_DEVIATION 15.279 • n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	79.69 kg STANDARD_DEVIATION 14.577 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	79.72 kg STANDARD_DEVIATION 17.633 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	78.81 kg STANDARD_DEVIATION 15.604 • n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Screening BMI Part 1	26.77 kg/m^2 STANDARD_DEVIATION 5.890 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	27.15 kg/m^2 STANDARD_DEVIATION 4.197 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	29.76 kg/m^2 STANDARD_DEVIATION 5.013 • n=8 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	27.89 kg/m^2 STANDARD_DEVIATION 5.046 • n=24 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.
Screening BMI Part 2	26.86 kg/m^2 STANDARD_DEVIATION 4.803 • n=15 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	28.93 kg/m^2 STANDARD_DEVIATION 4.868 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	28.59 kg/m^2 STANDARD_DEVIATION 6.053 • n=16 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.	28.15 kg/m^2 STANDARD_DEVIATION 5.250 • n=47 Participants • Part 1 and Part 2 were of different patient populations. Baseline demographic metrics were collected separately for each part.

PRIMARY outcome

Timeframe: Baseline to Day 28

Population: Population included subjects from Part 1 of the study and those who had received at least one dose of study medication.

Safety and tolerability endpoints will consist of all treatment-related adverse events reporting during the study duration for subjects only from Part 1 of the study.

Outcome measures

Measure	Vehicle n=8 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=8 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=8 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Drug Related Severe TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Drug Related TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Drug Related Serious TEAE	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Total Nasal Symptom Score (TNSS) is the sum of sub-scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea at each time point, using a four point scale (0-3; 0 = none; 1 = mild; 2 = moderate; 3 = severe), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the sub-score for each of the symptoms to a total out of 12. For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4.

Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment Observed AUC (0-2 Hours)	-5.1 score on a scale*hours Standard Deviation 3.53	-2.5 score on a scale*hours Standard Deviation 4.51	-4.9 score on a scale*hours Standard Deviation 3.66
Change in Total Nasal Symptom Score (TNSS) After Prophylaxis Treatment Pre-NAC Adjusted (0-2 Hours)	-5.9 score on a scale*hours Standard Deviation 3.88	-3.7 score on a scale*hours Standard Deviation 6.84	-4.9 score on a scale*hours Standard Deviation 3.29

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal congestion was categorized as None, Mild, Moderate, or Severe.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 2 (Day 0) · None	4 Participants	2 Participants	5 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 2 (Day 0) · Moderate	0 Participants	5 Participants	4 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 2 (Day 0) · Severe	3 Participants	3 Participants	3 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 3 (Day 14) · None	3 Participants	4 Participants	4 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 3 (Day 14) · Mild	4 Participants	3 Participants	4 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 4 (Day 28) · None	3 Participants	4 Participants	7 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 4 (Day 28) · Mild	8 Participants	6 Participants	6 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 4 (Day 28) · Severe	1 Participants	3 Participants	0 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 2 (Day 0) · Mild	8 Participants	6 Participants	4 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 3 (Day 14) · Moderate	6 Participants	5 Participants	5 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 3 (Day 14) · Severe	2 Participants	4 Participants	3 Participants
Subjective Nasal Symptom Scores of Nasal Congestion After Prophylaxis Treatment Visit 4 (Day 28) · Moderate	3 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Rhinorrhea was categorized as None, Mild, Moderate, or Severe.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 2 (Day 0) · None	8 Participants	9 Participants	8 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 2 (Day 0) · Mild	2 Participants	5 Participants	4 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 2 (Day 0) · Moderate	3 Participants	0 Participants	3 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 3 (Day 14) · None	5 Participants	6 Participants	6 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 2 (Day 0) · Severe	2 Participants	2 Participants	1 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 3 (Day 14) · Mild	6 Participants	5 Participants	5 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 3 (Day 14) · Moderate	3 Participants	1 Participants	3 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 3 (Day 14) · Severe	1 Participants	4 Participants	2 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 4 (Day 28) · None	11 Participants	10 Participants	10 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 4 (Day 28) · Mild	2 Participants	3 Participants	4 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 4 (Day 28) · Moderate	2 Participants	1 Participants	2 Participants
Subjective Nasal Symptom Scores of Rhinorrhea After Prophylaxis Treatment Visit 4 (Day 28) · Severe	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Nasal itching was categorized as None, Mild, Moderate, or Severe.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 2 (Day 0) · Moderate	2 Participants	1 Participants	3 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 2 (Day 0) · Severe	3 Participants	1 Participants	1 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 3 (Day 14) · None	6 Participants	7 Participants	9 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 3 (Day 14) · Moderate	5 Participants	3 Participants	2 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 4 (Day 28) · None	11 Participants	11 Participants	13 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 4 (Day 28) · Mild	4 Participants	3 Participants	3 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 4 (Day 28) · Severe	0 Participants	1 Participants	0 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 2 (Day 0) · None	6 Participants	10 Participants	10 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 2 (Day 0) · Mild	4 Participants	4 Participants	2 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 3 (Day 14) · Mild	4 Participants	5 Participants	4 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 3 (Day 14) · Severe	0 Participants	1 Participants	1 Participants
Subjective Nasal Symptom Scores of Nasal Itching After Prophylaxis Treatment Visit 4 (Day 28) · Moderate	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

All measurements were taken 120 minutes Post-Nasal Allergen Challenge (Post-NAC) at Visit 4 and compared to Baseline Visit 3. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline. Sneezing was categorized as None, Mild, Moderate, or Severe.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 2 (Day 0) · None	9 Participants	13 Participants	11 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 2 (Day 0) · Moderate	1 Participants	0 Participants	2 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 2 (Day 0) · Severe	0 Participants	0 Participants	0 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 3 (Day 14) · None	9 Participants	13 Participants	13 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 3 (Day 14) · Mild	5 Participants	1 Participants	1 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 3 (Day 14) · Moderate	1 Participants	2 Participants	1 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 3 (Day 14) · Severe	0 Participants	0 Participants	1 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 4 (Day 28) · None	10 Participants	13 Participants	13 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 4 (Day 28) · Mild	5 Participants	3 Participants	3 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 4 (Day 28) · Moderate	0 Participants	0 Participants	0 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 4 (Day 28) · Severe	0 Participants	0 Participants	0 Participants
Subjective Nasal Symptom Scores of Sneezing After Prophylaxis Treatment Visit 2 (Day 0) · Mild	5 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal congestion at Visit 4 (yes indicates subject is free from nasal congestion symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment Yes	3 Participants	4 Participants	7 Participants
Nasal Symptom-free Response Rate in Nasal Congestion Scores After Prophylaxis Treatment No	12 Participants	12 Participants	9 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to rhinorrhea at Visit 4 (yes indicates subject is free from rhinorrhea symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment Yes	11 Participants	10 Participants	10 Participants
Nasal Symptom-free Response Rate in Rhinorrhea Scores After Prophylaxis Treatment No	4 Participants	6 Participants	6 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to nasal itching at Visit 4 (yes indicates subject is free from nasal itching symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment No	4 Participants	5 Participants	3 Participants
Nasal Symptom-free Response Rate in Nasal Itching Scores After Prophylaxis Treatment Yes	11 Participants	11 Participants	13 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Nasal symptom free response rate was assessed 120 minutes Post-Nasal Allergen Challenge (Post-NAC) to be scored as Yes or No to sneezing at Visit 4 (yes indicates subject is free from sneezing symptom and no indicates subject still has nasal itching symptom). Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment Yes	10 Participants	13 Participants	13 Participants
Nasal Symptom-free Response Rate in Sneezing Scores After Prophylaxis Treatment No	5 Participants	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Number of subjects that had 25% and 50% reduction in Observed Area Under the Curve (AUC) (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes) at Visit 4 (Day 28) from Visit 2 Observed AUC (0-120 minutes)/Pre-NAC Adjusted AUC (0-120 minutes). For TNSS and Area Under the Curve (AUC) analyses, an Analysis of Covariance with treatment and site as factors and Visit 3 (or Visit 2) value as a covariate was used to test for treatment effect at Visit 4. Observed AUC (0-2 Hours) was defined as TNSS from 0 to 120 minutes post Nasal Allergen Challenge (NAC). The Pre-NAC Adjusted AUC (0-2 Hours) was defined as the observed value minus the 0 minutes prior NAC value.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 25% Reduction from Visit 2 Observed AUC (0-120 minutes) · Yes	9 Participants	6 Participants	12 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 25% Reduction from Visit 2 Observed AUC (0-120 minutes) · No	6 Participants	10 Participants	4 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 25% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) · No	6 Participants	8 Participants	1 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 25% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) · Yes	9 Participants	8 Participants	15 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 50% Reduction from Visit 2 Observed AUC (0-120 minutes) · Yes	3 Participants	3 Participants	6 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 50% Reduction from Visit 2 Observed AUC (0-120 minutes) · No	12 Participants	13 Participants	10 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 50% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) · Yes	7 Participants	6 Participants	8 Participants
Nasal Symptom-free Response Rate in TNSS After Prophylaxis Treatment 50% Reduction from Visit 2 Pre-NAC Adjusted AUC (0-120 minutes) · No	8 Participants	10 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Peak Nasal Inspiratory Flow (PNIF) is a commonly used method for assessing nasal patency and provides an objective measurement of nasal airflow obstruction. The outcome is a direct representation of nasal congestion. Change in PNIF Observed Inverted Area Under the Curve (AUC) was measured between baseline and Visit 4. A decrease in PNIF Observed Inverted AUC(0-2 Hours) was considered an improvement in nasal airflow obstruction. Visit 3 was considered Baseline. Visit 2 was considered an alternate Baseline.

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Change in Peak Nasal Inspiratory Flow (PNIF) Change from Visit 3 to Visit 4	-60.8 L*Hr/min Standard Deviation 57.83	-8.6 L*Hr/min Standard Deviation 39.62	-60.9 L*Hr/min Standard Deviation 57.48
Change in Peak Nasal Inspiratory Flow (PNIF) Change from Visit 2 to Visit 4	-51.2 L*Hr/min Standard Deviation 99.99	-30.4 L*Hr/min Standard Deviation 96.76	-59.8 L*Hr/min Standard Deviation 57.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Nasal inflammation were graded by a clinician using a 0-3 nasal inflammation scale based on otoscope measurement where 0 = none, 1 = mild, 2 = moderate, and 3 = severe inflammation 120 minutes Post Nasal Allergen Challenge (Post-NAC).

Outcome measures

Measure	Vehicle n=15 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=16 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Nasal Inflammation Score Using Otoscope Visit 3 (Day 14) · None	0 Participants	0 Participants	0 Participants
Nasal Inflammation Score Using Otoscope Visit 3 (Day 14) · Mild	5 Participants	4 Participants	8 Participants
Nasal Inflammation Score Using Otoscope Visit 3 (Day 14) · Moderate	8 Participants	10 Participants	8 Participants
Nasal Inflammation Score Using Otoscope Visit 3 (Day 14) · Severe	2 Participants	2 Participants	0 Participants
Nasal Inflammation Score Using Otoscope Visit 4 (Day 28) · None	2 Participants	2 Participants	6 Participants
Nasal Inflammation Score Using Otoscope Visit 4 (Day 28) · Mild	9 Participants	9 Participants	5 Participants
Nasal Inflammation Score Using Otoscope Visit 4 (Day 28) · Moderate	3 Participants	4 Participants	5 Participants
Nasal Inflammation Score Using Otoscope Visit 4 (Day 28) · Severe	1 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Population includes only patients from Part 2 of the study.

Exhaled nasal nitric oxide (NO) was measured from the nasal cavity by a NO analyzer 120 minutes Post Nasal Allergen Challenge (Post-NAC).

Outcome measures

Measure	Vehicle n=7 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	B 244 1x (Low Dose) n=8 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	B244 4x (Mid Dose) n=8 Participants Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Intranasal Nitric Oxide Levels Visit 3 (Day 14)	61.9 ppb Standard Deviation 57.77	33.9 ppb Standard Deviation 26.68	81.9 ppb Standard Deviation 104.88
Intranasal Nitric Oxide Levels Visit 4 (Day 28)	63.6 ppb Standard Deviation 55.42	27.3 ppb Standard Deviation 25.25	52.7 ppb Standard Deviation 41.13

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 3 (or alternative baseline at Visit 2) to Visit 4 (14 days prophylaxis treatment). Visit 2 was used as an alternate baseline to report baseline values prior to any nasal allergen challenge (NAC) to minimize any potential priming effects.

Population: Data was not collected for this exploratory endpoint.

To evaluate if B244 administration will affect the levels of cytokine biomarkers in nasal cavity and blood.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Vehicle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: B244 1x (Low Dose)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: B244 4x (Mid Dose)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: Vehicle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: B244 1x (Low Dose)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: B244 4x (Mid Dose)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1: Vehicle n=8 participants at risk Part 1 Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	Part 1: B244 1x (Low Dose) n=8 participants at risk Part 1 Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	Part 1: B244 4x (Mid Dose) n=8 participants at risk Part 1 Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle	Part 2: Vehicle n=15 participants at risk Part 2 Intranasal application: 1 pump (140ul) per nostril BID for 14 days Vehicle: Vehicle, 30ml/bottle	Part 2: B244 1x (Low Dose) n=16 participants at risk Part 2 Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (1x10E9 cells/ml) in 30ml/bottle	Part 2: B244 4x (Mid Dose) n=16 participants at risk Part 2 Intranasal application: 1 pump (140ul) per nostril BID for 14 days B244 suspension: B244 suspension (4x10E9 cells/ml) in 30ml/bottle
Ear and labyrinth disorders Ear congestion	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
General disorders Chest discomfort	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	12.5% 1/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Nervous system disorders Headache	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.7% 1/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	6.2% 1/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	12.5% 1/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.
Respiratory, thoracic and mediastinal disorders Nasal dryness	12.5% 1/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/8 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/15 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.	0.00% 0/16 • Part 1: Baseline to end of study (Day 42). Part 2: Baseline to end of study (Day 28). Population included subjects from Part 1 (n=24) and Part 2 (n=47) of the study and those who received at least 1 dose of IP. All clinical events were to be recorded in the CRF. AEs resulting from concurrent illnesses or reactions to concurrent medications were also to be recorded. Each adverse clinical event was evaluated for duration, intensity, and whether the event may be associated with the IP or other causes. AEs believed to be possibly related to IP must be followed until resolution.

Additional Information

Hyun Kim, Vice President Clinical Operations

AOBiome Therapeutics

Phone: 617-639-9980

Email: hkim@aobiome.com

Results disclosure agreements

• Principal investigator is a sponsor employee PI may not publish or otherwise publicly disclose the analyzed study data and conclusions drawn from the study.
• Publication restrictions are in place

Restriction type: OTHER