NCT02559258

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Tunitas Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Allergy and Immunology

Interventions

Type	Name	Description
DRUG	0.1 mg/kg epsi-gam or placebo (6:2)	administered as a single intravenous infusion on Day 1, infused over 30 minutes
DRUG	0.3 mg/kg epsi-gam or placebo (6:2)	administered as a single intravenous infusion on Day 1 infused over 30 minutes
DRUG	1.0 mg/kg epsi-gam or placebo (6:2)	administered as a single intravenous infusion on Day 1 infused over 30 minutes
DRUG	3 mg/kg epsi-gam or placebo (6:2)	administered as a single intravenous infusion on Day 1 infused over 60 minutes
DRUG	10 mg/kg epsi-gam or placebo (6:2)	administered as a single intravenous infusion on Day 1 infused over 120 minutes

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-09-24
• Last updated: 2016-06-17

Locations

1 site across 1 country: Australia