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Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JP-2266 | Experimental | Drug: JP-2266 |
|
| JP-2266 Placebo | Placebo Comparator | Drug: JP-2266 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JP-2266 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of the number of adverse events and the number and percentage of subjects | Single Ascending Dose | up to Day 10 |
| Assessment of PK parameter: Maximum plasma concentration (Cmax) | Food effect cohort | up to 72hours of each period |
| The evaluation of the number of adverse events and the number and percentage of subjects | Multiple Ascending Dose | up to Day 19 |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yves DONAZZOLO, MD, MSc, | Contact | 33-438-372-747 | YvesDonazzolo@eurofins.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OPTIMED clinical research | Recruiting | Gières | 38610 | France |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| JP-2266 Placebo | Drug |
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