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

NCT02559258 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2016-06-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tunitas Therapeutics Australia Pty Ltd

    collaborator UNKNOWN

  • Tunitas Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02559258 on ClinicalTrials.gov