A Phase 1/2 interventional study of BL-7010 and Placebo in Celiac Disease, sponsored by BioLineRx, Ltd.. Completed at 2 sites in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-08-18.
Sponsored by BioLineRx, Ltd. · Phase 1/2, Interventional, and Treatment
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.
333 studies on the registry are indexed under Celiac Disease; 77 are open to participants now.
This study's enrollment of 40 is below the median of 50 across 203 interventional studies indexed under Celiac Disease.
Browse Celiac Disease studies →BioLineRx, Ltd. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
Also known as: BL7010
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
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
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
Plasma levels of BL-7010
Time frame: Over a 24 hour period
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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BioLineRx, Ltd.