Escalating Single Dose Study of Epsi- Gam in Healthy Normal Subjects
Status:
Terminated
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
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.