Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers … (NCT03290248) | Clinical Trial Compass
CompletedPhase 1/2
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of B244 in Healthy Volunteers and Subjects With Seasonal Allergic Rhinitis
United States, Canada71 participantsStarted 2017-09-19
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0