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BL-7010

Phase 1

Celiac Disease | Small molecule | Gastrointestinal |BioLineRx Ltd.|Last Updated: Aug 18, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BL-7010 · 1 trial · 1 indication

Phase 1 1
NCT01990885Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.Celiac Disease
COMPLETED40 Analytics
PHASE1COMPLETED
Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients.
Celiac DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Plasma levels of BL-7010
Over a 24 hour period
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort AEXPERIMENTALEach 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
Cohort BEXPERIMENTALEach 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
Cohort CEXPERIMENTALEach 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
Cohort DEXPERIMENTALEach 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
Cohort EEXPERIMENTALEach 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

Interventions

NameTypeDescription
BL-7010DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

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 an...

Countries:Finland
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Frequently asked questions about BL-7010

What is BL-7010 used for?

BL-7010 is an investigational small molecule being developed for the treatment of celiac disease, a gastrointestinal condition. It is designed to address the needs of patients with this autoimmune disorder, though it is not yet approved and remains in clinical development.

Who makes BL-7010?

BL-7010 is being developed by BioLineRx Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BLRX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy for celiac disease.

What phase is BL-7010 in?

BL-7010 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is BL-7010 in?

BL-7010 has one completed Phase 1 clinical trial, identified as NCT01990885. This study, titled 'Safety and Systemic Exposure Study of BL-7010 in Well-Controlled Celiac Patients,' was conducted in Finland with 40 participants and evaluated the drug's safety and systemic exposure.

Is BL-7010 a controlled trial?

Yes, the Phase 1 clinical trial for BL-7010 (NCT01990885) was a randomized, double-blind, controlled study. It enrolled 40 adults aged 18 years and older with celiac disease, and the trial has been completed.