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

Phase 1

Terminated

• Conditions: Allergy and Immunology

• Registration Number: NCT02559258
• Lead Sponsor: Tunitas Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects who meet any of the following criteria must be excluded:

1. Diluent control elicits a wheal ≥ 3 mm on testing.
2. History of severe systemic allergic reactions to cats, dust mite, or Bermuda grass
3. Clinical history of persistent asthma
4. Dermatographism or any skin disorder (i.e., atopic dermatitis) that would make skin testing or proper interpretation impractical.
5. Chronic urticaria.
6. 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.
7. Any abnormal laboratory value(s) considered to be clinically significant by the Investigator.
8. Use of systemic corticosteroids within the past three months prior to initial screening.
9. Use of topical corticosteroids on the area(s) to undergo skin tests within the past three weeks prior to initial screening.
10. Use of systemic beta-blocking or ACE-inhibiting agents within the past three weeks prior to initial screening.
11. Use of tricyclic antidepressants within the past three weeks prior to initial screening.
12. Use of H2 antagonists within 24 hours prior to initial screening.
13. Use of any agents known or likely to interact with adrenaline.
14. Use of omalizumab (Xolair®) within the past six months prior to enrolment.
15. Pregnant females as determined by a positive serum or urine hCG test.
16. Lactating females.
17. Participation in another experimental drug or device trial and receipt of an investigational product within the past 30 days, five half-lives or twice the duration of the biochemical effect of the investigational product (whichever is longer) prior to dosing in the present study.
18. Any mental impairment as judged by the Investigator that would limit ability to comply with study requirements.
19. History of infection with, or positive screen for, Hepatitis B (HBsAg, Hepatitis B Surface Antigen), Hepatitis C (HCVAb, Hepatitis C Antibody), or Human Immunodeficiency Virus (HIV 1 or 2).
20. Positive urine screen for drugs of abuse. Positive ethanol breath test.
21. Concurrent disease or condition, that, in the opinion of the Investigator, places the subject at high risk of poor treatment compliance or of not completing the study.
22. Has smoked or consumed nicotine-containing products within past 3 months prior to receiving study drug or has a positive urine test for cotinine, and does not agree to refrain from smoking for the duration of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs	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.

Trial Locations

Locations (1)

Q-Pharm; 🇦🇺 Brisbane, Queensland, Australia