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

BioLineRx

Status and phase: Completed; Phase 2; Phase 1

Conditions: Celiac Disease

Treatments: Drug: BL-7010; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01990885

BL-7010.01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 5 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BL-7010

Cohort B

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BL-7010

Cohort C

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BL-7010

Cohort D

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BL-7010

Cohort E

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: BL-7010