Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of different amounts of BL-7010 in single oral administration and in repeated oral administration to well-controlled celiac patients. Another purpose is to evaluate if BL-7010 is absorbed by the body or not.

Official Title
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A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Systemic Exposure of Single Escalating Administrations and Repeated Administration of BL-7010 in Well-Controlled Celiac Patients

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: BL-7010
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged 18-75 years who have signed an informed consent form Body mass index (BMI) between 18.5-29.9, inclusive Documented history of biopsy-proven celiac disease. Adherence to a gluten-free diet for the last 6 months prior to randomization TG2 and EMA antibody (IgA) negative Women of childbearing potential and all men must agree to use an approved form of contraception Ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment. Exclusion Criteria: IgA deficiency. History of IgE-mediated reactions to gluten. Other food sensitivities or allergies. Use of oral steroids, biologics, immunosuppressants or non-steroidal anti-inflammatory drugs 6 months prior to entry (screening). Female subjects who are pregnant or breastfeeding. Clinically significant, concomitant gastrointestinal disease. Have clinically significant current or historical medical problems such as diabetes mellitus, clinically significant cardiac arrhythmias, arteriosclerotic heart disease, renal insufficiency or failure, autoimmune disease, history of malignant melanoma or history of cancer (excluding basal cell carcinoma) within the past 5 years prior to screening. Subjects receiving drugs or oral devices that, in the opinion of the Investigator, possible ineffective treatment with these drugs/oral devices for a duration of two weeks will put the subject at a medical risk Uncontrolled complications of celiac disease. Any other condition that in the opinion of the Investigator will place the subject at risk or prevent protocol compliance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A Two-Part, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Systemic Exposure Of Single Escalating Administrations And Repeated Administration Of Bl-7010 In Well-Controlled Celiac Patients
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Each subject will receive a single administration of either BL-7010 (at different amounts) or matching Placebo on 3 treatment occasions in a randomized double-blind fashion | Drug: BL-7010<br> <br> * Other names: BL7010;Drug: Placebo<br> <br> |
| Experimental: Cohort B<br>Each subject will receive a single administration of either BL-7010 (at different amounts) or matching Placebo on 3 treatment occasions in a randomized double-blind fashion | Drug: BL-7010<br> <br> * Other names: BL7010;Drug: Placebo<br> <br> |
| Experimental: Cohort C<br>Each Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from Cohorts A and B) in a randomized double-blind fashion | Drug: BL-7010<br> <br> * Other names: BL7010;Drug: Placebo<br> <br> |
| Experimental: Cohort D<br>Each Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from previous cohorts) in a randomized double-blind fashion | Drug: BL-7010<br> <br> * Other names: BL7010;Drug: Placebo<br> <br> |
| Experimental: Cohort E<br>Each Subject will receive either BL-7010 or Placebo 3 times a day for 14 days(amount to be based on results from previous cohorts) in a randomized double-blind fashion | Drug: BL-7010<br> <br> * Other names: BL7010;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration | 
| Significant change from baseline in vital signs and 12-lead ECG parameters |  | For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration | 
| Significant change from baseline in laboratory safety parameters |  | For Part 1 subjects will be followed for up to 7 weeks from time of first administration. For Part 2 subjects will be followed for up to 4 weeks from time of first administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of BL-7010 |  | Over a 24 hour period |