Escalating Single Dose Study of Epsi- Gam in Healthy Normal Subjects

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.

Timeline

Start

2015-08

Primary completion

2016-05

Completion

2016-05

Outcome

Outcome not reported

Stopped (Business): “Sponsor Decision”

Drugs

Indications