A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Epsi- Gam in Healthy, Cat-, Dust Mite-, or Bermuda Grass-Allergic Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Allergy and Immunology
- Sponsor
- Tunitas Therapeutics, Inc.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
This is a single-center, randomized, double-blind, placebo-controlled, single-dose, dose- escalation study in otherwise healthy cat-, dust mite-, or Bermuda grass-allergic male and female subjects. There will be five dosing cohorts (0.1, 0.3, 1.0, 3.0 and 10.0 mg/kg), with eight subjects in each cohort, randomized to either epsi-gam (6 subjects) or placebo (2 subjects) for a total of 40 subjects. The first cohort will receive the starting dose of 0.1 mg/kg epsi-gam or placebo and subsequent cohorts will be recruited sequentially to receive escalating doses of epsi-gam or placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Subjects who meet any of the following criteria must be excluded:
- •Diluent control elicits a wheal ≥ 3 mm on testing.
- •History of severe systemic allergic reactions to cats, dust mite, or Bermuda grass
- •Clinical history of persistent asthma
- •Dermatographism or any skin disorder (i.e., atopic dermatitis) that would make skin testing or proper interpretation impractical.
- •Chronic urticaria.
- •Underlying heart, liver, kidney, or lung disease or any other medical condition such that the subject would be at increased risk for a poor outcome should a generalized allergic or other reaction occur.
- •Any abnormal laboratory value(s) considered to be clinically significant by the Investigator.
- •Use of systemic corticosteroids within the past three months prior to initial screening.
- •Use of topical corticosteroids on the area(s) to undergo skin tests within the past three weeks prior to initial screening.
Outcomes
Primary Outcomes
Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs
Time Frame: From start of study drug administration through Day 57 (+/- 2 days)
ECGs, clinical laboratory values (including clinically significant changes from baseline) from blood and urine samples, performing physical examinations and pregnancy tests and reviewing concomitant medications.