ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03290248
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Orange County Research Center
Integrium
Information provided by (Responsible Party):
AOBiome LLC

Brief Summary:
This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Rhinitis Due to Grass Pollen Healthy Volunteers Biological: B244 suspension Biological: Vehicle Phase 1 Phase 2

Detailed Description:

This is a Prospective, Controlled, Double Blinded, Single Center, Randomized, 3 Arm, Parallel Assignment, Phase 1b/2a Study to assess the safety, tolerability, and preliminary efficacy of B244 delivered as an intranasal spray in healthy volunteers and subjects with seasonal allergic rhinitis. This will be a 2-part study. In Part 1, safety and tolerability will be evaluated during 14 days of study treatment twice-a-day followed by 4 weeks of follow-up in healthy volunteers. In Part 2, preliminary efficacy will be evaluated in subjects with a history of seasonal allergic rhinitis outside of the local pollen season.

For Part 1 (safety and tolerability evaluation in healthy volunteers) we will enroll 24 subjects. Safety and tolerability will be assessed by reporting of AEs, physical examination and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment and up to 28 days of follow-up.

An internal safety committee meeting will review the 2 week Part 1 safety data and, if there are no safety concerns, the study will proceed to Part 2 to evaluate preliminary efficacy in subjects with a history of seasonal allergic rhinitis (SAR)

For Part 2 (preliminary efficacy evaluation in subjects with a history of SAR to ragweed pollen) will enroll 42 subjects. Safety and tolerability will be assessed in subjects with allergic rhinitis by reporting of AEs, physical examination and vital signs (blood pressure, heart rate, respiratory rate) during 14 days of treatment.

For Part 2, study will be paused for safety review using the same stopping criteria as in Part 1.

Rescue medications will not be allowed during the study.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization will be 1:1:1 so that equal number of subjects will be treated in each arm of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double blind study.
Primary Purpose: Treatment
Official Title: A Prospective, Controlled, Double Blind, Single Center, Randomized, 3 Arm, Phase 1b/2a Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 Delivered as an Intranasal Spray in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
Actual Study Start Date : September 19, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Placebo Comparator: Vehicle

Intranasal application:

1 pump (140ul) per nostril BID for 14 days

Biological: Vehicle
Vehicle, 30ml/bottle

Active Comparator: B 244 1x (low dose)

Intranasal application:

1 pump (140ul) per nostril BID for 14 days

Biological: B244 suspension
B244 suspension in 30ml/bottle

Active Comparator: B244 4x (mid dose)

Intranasal application:

1 pump (140ul) per nostril BID for 14 days

Biological: B244 suspension
B244 suspension in 30ml/bottle




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Baseline to Day 28 ]

Secondary Outcome Measures :
  1. Change in Total Nasal Symptom Score (TNSS) after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  2. Change in subjective nasal symptom scores of nasal congestion after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  3. Change in subjective nasal symptom scores of rhinorrhea after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  4. Change in subjective nasal symptom scores of nasal itching after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  5. Change in subjective nasal symptom scores of sneezing after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  6. Change in nasal symptom-free response rate in nasal congestion scores after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  7. Change in nasal symptom-free response rate in rhinorrhea scores after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  8. Change in nasal symptom-free response rate in nasal itching scores after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  9. Change in nasal symptom-free response rate in sneezing scores after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]
  10. Change in nasal symptom-free response rate in TNSS after prophylaxis treatment [ Time Frame: Baseline to Day 14 ]

Other Outcome Measures:
  1. Change in Peak Nasal Inspiratory Flow (PNIF) score [ Time Frame: Baseline to Day 14 ]
  2. Change in nasal inflammation score using otoscope [ Time Frame: Baseline to Day 14 ]
  3. Change in intranasal nitric oxide levels [ Time Frame: Baseline to Day 14 ]
  4. Change in cytokine concentration in nasal cavity and blood [ Time Frame: Baseline to Day 14 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and Females, 18 to 65 years of age (committed to consistent use of an acceptable method of birth control as described in Section 10).
  • In good general health as determined by a thorough medical history and physical examination, and vital signs.
  • Nonsmoker or ex-smoker (stopped >1 year prior to study entry).
  • Subjects willing and able to provide written informed consent.
  • Is willing and able to comply with the requirements of the protocol and must be available for the full duration of the study.
  • For Part 1, subjects asymptomatic from any seasonal or perennial allergens.
  • For Part 1, elevated systolic blood pressure greater than 120 but less than 160 and never been on antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer.
  • For Part 2, subjects with a well-documented history of seasonal allergic rhinitis (specifically ragweed pollen) with documentation of sensitivity by positive skin testing and/or IgE testing to the relevant allergens 12 months prior to enrollment that correlate with clinical history.
  • For Part 2, a ragweed positive skin prick test with a wheal diameter at least 5 mm larger than the negative control and/or a ragweed specific IgE greater or equal to 0.7 kU/L.
  • For Part 2, subjects with confounding allergies, or sensitization to cat epithelia, dog epithelia, Dermatophagoides farinae, or Dermatophagoides pteronyssinus or prevalent and relevant seasonal allergens as per the skin prick test may be included if sensitization is not clinically relevant (ie. subject is non-symptomatic and/or can avoid the allergen during the study) at the discretion of the Investigator.
  • For Part 2, subjects with a baseline TNSS ≤ 3/12 at Visit 3 and a minimum qualifying TNSS score of a change of 6/12 from their baseline score after NAC #1 on at least 2 diary cards.
  • For Part 2, subjects' average post diluents nasal congestion score must be < 1 at admission for each study visit.

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Female of childbearing potential not using adequate contraceptive measures.
  • Smoking within the past year or during the protocol.
  • Systemic corticosteroid or other immunosuppressive medications use in the previous three months or during the protocol.*
  • Intranasal corticosteroid use in the previous month or during the protocol.*
  • Intranasal antihistamine or cromolyn use in the previous week or during the study.*
  • Allergen immunotherapy during previous 12 months or during the protocol.*
  • Omalizumab use in previous 12 months or during the protocol.*
  • Systemic antihistamine or leukotriene modifying medication use in the previous week or during the protocol.*
  • Use of antibiotics, NSAIDS, antihypertensives, beta-blockers, photosensitizing medications, or vitamin D supplements during study.
  • Use of any intranasally administered over-the-counter product or nasal irrigation (e.g., neti pot) during study.
  • Inability to give informed consent.
  • Persistent asthma or any medical condition that in the opinion of the investigator may compromise the subject's ability to safely participate in the study.
  • Subjects with any significant clinical abnormalities which may interfere with study participation.
  • Prior use of AO+ Mist.
  • Subjects with immunodeficiencies, nasal lesions, nasal polyps, or sinus infections.
  • Use of an investigational drug within 30 days before screening Visit 1. * Exclusionary criterion due to 1) medication use as marker of persistent comorbid allergic or inflammatory condition that may increase subject risk with study participation, 2) potential of medication to interfere with study outcome measures or results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290248


Contacts
Contact: Hyun Kim, PhD 617-475-1605 hkim@aobiome.com

Locations
United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
Contact: Joel Neutel, MD    714-550-9990      
Sponsors and Collaborators
AOBiome LLC
Orange County Research Center
Integrium
Investigators
Principal Investigator: Joel Neutel, MD Study PI

Responsible Party: AOBiome LLC
ClinicalTrials.gov Identifier: NCT03290248     History of Changes
Other Study ID Numbers: ARB244-001
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases