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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioLineRx, Ltd.
ClinicalTrials.gov Identifier:
NCT01990885
First received: November 17, 2013
Last updated: July 30, 2015
Last verified: July 2015
  Purpose

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 Intervention Phase
Celiac Disease
Device: BL-7010
Device: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by BioLineRx, Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma levels of BL-7010 [ Time Frame: Over a 24 hour peiord ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: BL-7010 Device: 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
Device: BL-7010 Device: 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
Device: BL-7010 Device: 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
Device: BL-7010 Device: 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
Device: BL-7010 Device: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990885

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 University of Tampere
  More Information

No publications provided

Responsible Party: BioLineRx, Ltd.
ClinicalTrials.gov Identifier: NCT01990885     History of Changes
Other Study ID Numbers: BL-7010.01
Study First Received: November 17, 2013
Last Updated: July 30, 2015
Health Authority: Finland: Valvira - National Supervisory Authority for Welfare and Health

Additional relevant MeSH terms:
Celiac Disease
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases

ClinicalTrials.gov processed this record on August 31, 2015