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

• ClinicalTrials.gov Identifier: NCT01990885
• Recruitment Status: Completed
• First Posted: November 25, 2013
• Last Update Posted: August 18, 2017
• Sponsor: BioLineRx, Ltd.
• Information provided by (Responsible Party): BioLineRx, Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Celiac Disease	Drug: BL-7010; Drug: Placebo	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: December 2013
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort A; 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; Other Name: BL7010; Drug: Placebo
Experimental: Cohort B; 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; Other Name: BL7010; Drug: Placebo
Experimental: Cohort C; 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; Other Name: BL7010; Drug: Placebo
Experimental: Cohort D; 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; Other Name: BL7010; Drug: Placebo
Experimental: Cohort E; 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; Other Name: BL7010; Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Incidence of adverse events [ Time Frame: 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 ]
2. Significant change from baseline in vital signs and 12-lead ECG parameters [ Time Frame: 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 ]
3. Significant change from baseline in laboratory safety parameters [ Time Frame: 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 :

1. Plasma levels of BL-7010 [ Time Frame: Over a 24 hour period ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Finland

FinnMedi Clinical Trial Center

Tampere, Finland

CRST Clinical Research Services

Turku, Finland

Sponsors and Collaborators

BioLineRx, Ltd.

Investigators

• Principal Investigator: Markku Mäki, Professor; Tampere University

More Information

• Responsible Party: BioLineRx, Ltd.
• ClinicalTrials.gov Identifier: NCT01990885
• Other Study ID Numbers: BL-7010.01
• First Posted: November 25, 2013
• Last Update Posted: August 18, 2017
• Last Verified: August 2017

Additional relevant MeSH terms:

Celiac Disease; Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases