Back to resultsSafety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.
Primary Purpose
Celiac Disease
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
BL-7010
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Celiac Disease
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.
Sites / Locations
- FinnMedi Clinical Trial Center
- CRST Clinical Research Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort A
Cohort B
Cohort C
Cohort D
Cohort E
Arm 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
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
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
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
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
Outcomes
Primary Outcome Measures
Incidence of adverse events
Significant change from baseline in vital signs and 12-lead ECG parameters
Significant change from baseline in laboratory safety parameters
Secondary Outcome Measures
Plasma levels of BL-7010
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01990885
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioLineRx, Ltd.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort A
Arm Type
Experimental
Arm 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
Arm Title
Cohort B
Arm Type
Experimental
Arm 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
Arm Title
Cohort C
Arm Type
Experimental
Arm 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
Arm Title
Cohort D
Arm Type
Experimental
Arm 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
Arm Title
Cohort E
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
BL-7010
Other Intervention Name(s)
BL7010
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Measure Information:
Title
Plasma levels of BL-7010
Time Frame
Over a 24 hour period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markku Mäki, Professor
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
FinnMedi Clinical Trial Center
City
Tampere
Country
Finland
Facility Name
CRST Clinical Research Services
City
Turku
Country
Finland
12. IPD Sharing Statement
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Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.
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