Celiac Disease
Conditions
Brief summary
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.
Interventions
DRUGBL-7010
DRUGPlacebo
Sponsors
BioLineRx, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Plasma levels of BL-7010 | Over a 24 hour period |
Countries
Finland
Outcome results
None listed