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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-7010 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of BL-7010 | Over a 24 hour period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markku Mäki, Professor | Tampere University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FinnMedi Clinical Trial Center | Tampere | Finland | ||||
| CRST Clinical Research Services |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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
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| Placebo | Drug |
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| Turku |
| Finland |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |