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

NCT03290248 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-11-25

Study results available
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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.

Conditions

  • Allergic Rhinitis
  • Allergic Rhinitis Due to Grass Pollen
  • Healthy Volunteers

Interventions

BIOLOGICAL

B244 suspension

B244 suspension in 30ml/bottle

BIOLOGICAL

Vehicle

Vehicle, 30ml/bottle

Sponsors & Collaborators

  • Orange County Research Center

    collaborator OTHER

  • Integrium

    collaborator INDUSTRY

  • AOBiome LLC

    lead INDUSTRY

Principal Investigators

  • Joel Neutel, MD · Study PI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2018-12-21
Completion
2018-12-21
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03290248 on ClinicalTrials.gov