A Phase 1/2 Open-Label, Single Ascending Dose, First-In-Human Study to Assess Safety and Tolerability of Endoscopic Ultrasound-Guided Pancreatic Infusion of RJVA-001 in Adults With Inadequately Controlled Type 2 Diabetes on Multiple Glucose-Lowering Agents.
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Type 2 Diabetes
Спонсор: Fractyl Health Inc.
Налично на:
БГ
Обобщение
Trial status: Authorised
1. Change in transgene secretion and glycemic parameters., 2. Anti-AAV9 antibody titers, anti-GLP-1 antibody titers and enzyme-linked immunosorbent spot for AAV9 and GLP-1., 3. Digital polymerase chain reaction for AAV9 in samples., 4. Change from Baseline parameters using continuous glucose monitoring.
Incidence, severity, dose-relationship of Adverse Events and changes in laboratory evaluations.
Описание
1. Change in transgene secretion and glycemic parameters., 2. Anti-AAV9 antibody titers, anti-GLP-1 antibody titers and enzyme-linked immunosorbent spot for AAV9 and GLP-1., 3. Digital polymerase chain reaction for AAV9 in samples., 4. Change from Baseline parameters using continuous glucose monitoring.
Кой може да участва
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 15 participants
БГ
EN