Clinical trial NCT01990885: Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Celiac Disease
Lead sponsor: BioLineRx, Ltd.
Sponsor class: INDUSTRY
First posted: 2013-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 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
measure: Significant change from baseline in vital signs and 12-lead ECG parameters
timeFrame: 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
measure: Significant change from baseline in laboratory safety parameters
timeFrame: 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 outcomes:
measure: Plasma levels of BL-7010
timeFrame: Over a 24 hour period
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: FinnMedi Clinical Trial Center
city: Turku
country: Finland
facility: CRST Clinical Research Services
Study officials:
affiliation: Tampere University
name: Markku Mäki, Professor
role: PRINCIPAL_INVESTIGATOR
References: