Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Key2Compliance | INDUSTRY |
| CRS Clinical Research Services Mannheim GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is a single-site, randomized, double-blinded, placebo-controlled, First-in-Human trial, conducted in 3 parts.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase A | Experimental | ATR-258 Single Ascending Dose or placebo |
|
| Phase B | Experimental | ATR-258 Multiple Ascending Dose or placebo |
|
| Phase C | Experimental | ATR-258 Repeated dosing or placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATR-258 | Drug | Single Ascending Dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety analyses after single dose of ATR-258 | Safety analyses will be performed based in incidence of TEAEs after single dose of ATR-258 | maximum 7 days post dosing |
| Safety analyses after multiple doses of ATR-258 | Safety analyses will be performed based in incidence of TEAEs after multiple doses of ATR-258 | maximum 56 days post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK analyses will be performed after PK of ATR-258 single dose | PK analyses will be performed based on AUC0-inf of ATR-258 in plasma | maximum 7 days post dosing |
| PK analyses will be performed after PK of ATR-258 single dose |
Not provided
Inclusion Criteria Phase A and B:
Inclusion Criteria Phase C:
Exclusion Criteria Phase C:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services | Mannheim | Germany |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ATR-258 |
| Drug |
Multiple Ascending Dose |
|
|
| ATR-258 | Drug | Repeat Dose |
|
|
PK analyses will be performed based on AUC0-tz of ATR-258 in plasma
| maximum 7 days post dosing |
| PK analyses will be performed after PK of ATR-258 single dose | PK analyses will be performed based on Cmax of ATR-258 in plasma | maximum 7 days post dosing |
| PK analyses will be performed after PK of ATR-258 multiple dose | PK analyses will be performed based on AUCtau of ATR-258 in plasma | maximum 56 days post dosing |
| PK analyses will be performed after PK of ATR-258 multiple dose | PK analyses will be performed based on AUC0-tz,MD of ATR-258 in plasma | maximum 56 days post dosing |
| PK analyses will be performed after PK of ATR-258 multiple dose | PK analyses will be performed based on Cmax,MD of ATR-258 in plasma | maximum 56 days post dosing |
| D004700 | Endocrine System Diseases |