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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02559258




Registration number
NCT02559258
Ethics application status
Date submitted
2/09/2015
Date registered
24/09/2015
Date last updated
17/06/2016

Titles & IDs
Public title
Escalating Single Dose Study of Epsi- Gam in Healthy Normal Subjects
Scientific title
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
Secondary ID [1] 0 0
TUN001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergy and Immunology 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 0.1 mg/kg epsi-gam or placebo (6:2)
Treatment: Drugs - 0.3 mg/kg epsi-gam or placebo (6:2)
Treatment: Drugs - 1.0 mg/kg epsi-gam or placebo (6:2)
Treatment: Drugs - 3 mg/kg epsi-gam or placebo (6:2)
Treatment: Drugs - 10 mg/kg epsi-gam or placebo (6:2)

Experimental: Cohort 1 -

Experimental: Cohort 2 -

Experimental: Cohort 3 -

Experimental: Cohort 4 -

Experimental: Cohort 5 -


Treatment: Drugs: 0.1 mg/kg epsi-gam or placebo (6:2)
administered as a single intravenous infusion on Day 1, infused over 30 minutes

Treatment: Drugs: 0.3 mg/kg epsi-gam or placebo (6:2)
administered as a single intravenous infusion on Day 1 infused over 30 minutes

Treatment: Drugs: 1.0 mg/kg epsi-gam or placebo (6:2)
administered as a single intravenous infusion on Day 1 infused over 30 minutes

Treatment: Drugs: 3 mg/kg epsi-gam or placebo (6:2)
administered as a single intravenous infusion on Day 1 infused over 60 minutes

Treatment: Drugs: 10 mg/kg epsi-gam or placebo (6:2)
administered as a single intravenous infusion on Day 1 infused over 120 minutes

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability will be assessed by monitoring AEs (frequency and severity) and SAEs, vital signs, PFTs - 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.
Timepoint [1] 0 0
From start of study drug administration through Day 57 (+/- 2 days)

Eligibility
Key inclusion criteria
Eligible subjects must meet all of the following inclusion criteria:

1. Be informed of the nature of the study and provide written informed consent prior to
undergoing screening procedures.

2. 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

3. 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

4. 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.

5. Have a Body Mass Index (BMI) within the range of 18.5 to 30.0 kg/m2.

6. Have a history of allergic reactivity to cats, dust mite, or Bermuda grass as
expressed by allergic symptoms including rhinitis.

7. 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.

8. Have allergen-specific IgE for cat, dust mite, or Bermuda grass as measured by
ImmunoCAP® with a Class rating of 1 or greater.

9. Histamine reactivity of 3 mm or greater, with surrounding erythema, on testing using a
standardized epicutaneous delivery device.

10. 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.

11. Have baseline spirometry (FEV1, FVC, FEF 25%-75%) with FEV1 = 80% predicted and other
values within the normal range.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Tunitas Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Tunitas Therapeutics Australia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02559258
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02559258