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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
FinnMedi Clinical Trial Center
Tampere, Finland
CRST Clinical Research Services
Turku, Finland
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
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