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

NCT01990885 | Completed Phase 1

• 1 other identifier: BL-7010.01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Plasma levels of BL-7010

  Over a 24 hour period

Study Arms (5)

Cohort A

EXPERIMENTAL

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; Drug: Placebo

Cohort B

EXPERIMENTAL

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; Drug: Placebo

Cohort C

EXPERIMENTAL

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; Drug: Placebo

Cohort D

EXPERIMENTAL

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; Drug: Placebo

Cohort E

EXPERIMENTAL

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; Drug: Placebo

Interventions

BL-7010 DRUG

Also known as: BL7010

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E

Placebo DRUG

Cohort A; Cohort B; Cohort C; Cohort D; Cohort E

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioLineRx, Ltd.: lead

Study Sites (2)

FinnMedi Clinical Trial Center

Tampere, Finland

Location

CRST Clinical Research Services

Turku, Finland

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Markku Mäki, Professor

  Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: November 17, 2013
• First Posted: November 25, 2013
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

FI (2)