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Clinical Trial Details

Trial ID: L4219
Source ID: NCT05409924
Associated Drug: Atr-258
Title: First-in-human Single and Multiple Dose Trial of ATR-258
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ATR-258|DRUG: ATR-258|DRUG: ATR-258
Outcome Measures: Primary: 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 | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: Atrogi AB | Collaborators: Key2Compliance|CRS Clinical Research Services Mannheim GmbH
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 71
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2022-04-11
Completion Date: 2023-10-04
Results First Posted:
Last Update Posted: 2023-12-18
Locations: CRS Clinical Research Services, Mannheim, Germany
URL: https://clinicaltrials.gov/show/NCT05409924