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

Celiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990885
• Other study ID #: BL-7010.01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 17, 2013
• Last updated: August 16, 2017
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2017
• Source: BioLineRx, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• BL-7010

• Placebo

Locations

Country	Name	City	State
Finland	FinnMedi Clinical Trial Center	Tampere
Finland	CRST Clinical Research Services	Turku

Sponsors (1)

Lead Sponsor	Collaborator
BioLineRx, Ltd.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		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
Primary	Significant change from baseline in vital signs and 12-lead ECG parameters		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
Primary	Significant change from baseline in laboratory safety parameters		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	Plasma levels of BL-7010		Over a 24 hour period