- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02559258
Escalating Single Dose Study of Epsi- Gam in Healthy Normal Subjects
June 15, 2016 updated by: Tunitas Therapeutics, Inc.
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
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia, 4006
- Q-Pharm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Eligible subjects must meet all of the following inclusion criteria:
- Be informed of the nature of the study and provide written informed consent prior to undergoing screening procedures.
- Be a healthy male of any race or ethnicity, at least 18 years of age and no more than 65 years of age, inclusively, OR
- Be a healthy female of any race or ethnicity of non-childbearing potential, at least 18 years of age and no more than 65 years of age, inclusively, OR
- Be a healthy non-pregnant, non-lactating female of any race or ethnicity of childbearing potential, at least 18 years of age and no more than 65 years of age, inclusive, with a negative pregnancy test who agrees to use 2 medically acceptable forms of birth control from Screening through 57 days after receiving study drug.
- Have a Body Mass Index (BMI) within the range of 18.5 to 30.0 kg/m2.
- Have a history of allergic reactivity to cats, dust mite, or Bermuda grass as expressed by allergic symptoms including rhinitis.
- Standardized cat allergenic extract (10,000 BAU/mL, ALK- Abello), dust mite allergenic extract (10,000 AU/mL, ALK- Abello), dust mite allergenic extract (10,000 AU/mL, ALK- Abello), or Bermuda grass allergenic extract (10,000 BAU/mL, ALK- Abello) elicits a wheal at least 5 mm up to approximately 10-15 mm in diameter that exceeds two diluent controls by at least 4 mm.
- Have allergen-specific IgE for cat, dust mite, or Bermuda grass as measured by ImmunoCAP® with a Class rating of 1 or greater.
- Histamine reactivity of 3 mm or greater, with surrounding erythema, on testing using a standardized epicutaneous delivery device.
- Be able and willing to discontinue any first and second generation antihistamine use beginning at least 7 days prior to undergoing initial screening skin puncture tests and throughout study participation.
- Have baseline spirometry (FEV1, FVC, FEF 25%-75%) with FEV1 ≥ 80% predicted and other values within the normal range.
Exclusion Criteria:
Subjects who meet any of the following criteria must be excluded:
- Diluent control elicits a wheal ≥ 3 mm on testing.
- History of severe systemic allergic reactions to cats, dust mite, or Bermuda grass
- Clinical history of persistent asthma
- Dermatographism or any skin disorder (i.e., atopic dermatitis) that would make skin testing or proper interpretation impractical.
- Chronic urticaria.
- 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.
- Any abnormal laboratory value(s) considered to be clinically significant by the Investigator.
- Use of systemic corticosteroids within the past three months prior to initial screening.
- Use of topical corticosteroids on the area(s) to undergo skin tests within the past three weeks prior to initial screening.
- Use of systemic beta-blocking or ACE-inhibiting agents within the past three weeks prior to initial screening.
- Use of tricyclic antidepressants within the past three weeks prior to initial screening.
- Use of H2 antagonists within 24 hours prior to initial screening.
- Use of any agents known or likely to interact with adrenaline.
- Use of omalizumab (Xolair®) within the past six months prior to enrolment.
- Pregnant females as determined by a positive serum or urine hCG test.
- Lactating females.
- 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.
- Any mental impairment as judged by the Investigator that would limit ability to comply with study requirements.
- 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).
- Positive urine screen for drugs of abuse. Positive ethanol breath test.
- 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.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
|
administered as a single intravenous infusion on Day 1, infused over 30 minutes
|
Experimental: Cohort 2
|
administered as a single intravenous infusion on Day 1 infused over 30 minutes
|
Experimental: Cohort 3
|
administered as a single intravenous infusion on Day 1 infused over 30 minutes
|
Experimental: Cohort 4
|
administered as a single intravenous infusion on Day 1 infused over 60 minutes
|
Experimental: Cohort 5
|
administered as a single intravenous infusion on Day 1 infused over 120 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs
Time Frame: 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.
|
From start of study drug administration through Day 57 (+/- 2 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
September 2, 2015
First Submitted That Met QC Criteria
September 23, 2015
First Posted (Estimate)
September 24, 2015
Study Record Updates
Last Update Posted (Estimate)
June 17, 2016
Last Update Submitted That Met QC Criteria
June 15, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- TUN001-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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