Allergy and ImmunologyPhase 1NCT02559258
Escalating Single Dose Study of Epsi- Gam in Healthy Normal Subjects
A Phase 1 study of Allergy and Immunology, run by Tunitas Therapeutics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy and Immunology
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- Aug 2015to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- 0.1 mg/kg epsi-gam or placebo (6:2), 0.3 mg/kg epsi-gam or placebo (6:2), 1.0 mg/kg epsi-gam or placebo (6:2), 3 mg/kg epsi-gam or placebo (6:2), 10 mg/kg epsi-gam or placebo (6:2)
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.1 mg/kg epsi-gam or placebo (6:2)Drug
administered as a single intravenous infusion on Day 1, infused over 30 minutes
0.3 mg/kg epsi-gam or placebo (6:2)Drug
administered as a single intravenous infusion on Day 1 infused over 30 minutes
1.0 mg/kg epsi-gam or placebo (6:2)Drug
administered as a single intravenous infusion on Day 1 infused over 30 minutes
3 mg/kg epsi-gam or placebo (6:2)Drug
administered as a single intravenous infusion on Day 1 infused over 60 minutes
10 mg/kg epsi-gam or placebo (6:2)Drug
administered as a single intravenous infusion on Day 1 infused over 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: 0.1 mg/kg epsi-gam or placebo (6:2) |
| Cohort 2 | Experimental | Not described Receives: Drug: 0.3 mg/kg epsi-gam or placebo (6:2) |
| Cohort 3 | Experimental | Not described Receives: Drug: 1.0 mg/kg epsi-gam or placebo (6:2) |
| Cohort 4 | Experimental | Not described Receives: Drug: 3 mg/kg epsi-gam or placebo (6:2) |
| Cohort 5 | Experimental | Not described Receives: Drug: 10 mg/kg epsi-gam or placebo (6:2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of study drug administration through Day 57 (+/- 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy and ImmunologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunitas Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tunitas Therapeutics Australia Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559258
- Sponsor's protocol ID
- TUN001-101
- Status last verified
- Jun 2016
- First submitted
- 2 Sep 2015
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02559258
- Acronym / sponsor ID
- TUN001-101
- Conditions
- Allergy and Immunology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Tunitas Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tunitas Therapeutics Australia Pty Ltd
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: 0.1 mg/kg epsi-gam or placebo (6:2) |
| Cohort 2 | Experimental | Drug: 0.3 mg/kg epsi-gam or placebo (6:2) |
| Cohort 3 | Experimental | Drug: 1.0 mg/kg epsi-gam or placebo (6:2) |
| Cohort 4 | Experimental | Drug: 3 mg/kg epsi-gam or placebo (6:2) |
| Cohort 5 | Experimental | Drug: 10 mg/kg epsi-gam or placebo (6:2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.1 mg/kg epsi-gam or placebo (6:2)administered as a single intravenous infusion on Day 1, infused over 30 minutes | Drug | Cohort 1 |
| 0.3 mg/kg epsi-gam or placebo (6:2)administered as a single intravenous infusion on Day 1 infused over 30 minutes | Drug | Cohort 2 |
| 1.0 mg/kg epsi-gam or placebo (6:2)administered as a single intravenous infusion on Day 1 infused over 30 minutes | Drug | Cohort 3 |
| 3 mg/kg epsi-gam or placebo (6:2)administered as a single intravenous infusion on Day 1 infused over 60 minutes | Drug | Cohort 4 |
| 10 mg/kg epsi-gam or placebo (6:2)administered as a single intravenous infusion on Day 1 infused over 120 minutes | Drug | Cohort 5 |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
Related trials for Allergy and Immunology
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma
RecruitingObservational study
Metabolic Profiling of Immune Responses in Immune-mediated Diseases
Primary Immunodeficiency, Psoriasis
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
Hereditary Angioedema (HAE)
Recruiting
Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg
Allergy and Immunology, Peanut and Nut Allergy
Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Allergy and Immunology, run by Tunitas Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.