Phase 2Recruiting
Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin in Werner Syndrome
A Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin for the Treatment of Bone Mineral Density (BMD) Loss in Subjects With Typical Werner Syndrome
- Sponsor
- PRG Science & Technology Co., Ltd. (Industry)
- Enrolment
- 5 planned
- Conditions
- Werner Syndrome
- Interventions
- Progerinin
- Ages
- adults, older adults
- Registry
- NCT05847179
From the registry
This is a Phase 2, open-label study to A Phase 2, Open-Label Study to Evaluate the Safety and Tolerability of Progerinin for the Treatment of Bone Mineral Density (BMD) Loss in Subjects with Typical Werner Syndrome. There will be up to 5 subjects that will receive treatment with Progerinin twice daily for approximately 1 year.
Primary outcomes
- Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
- Incidence of Treatment-Related Adverse Events
- Incidence of Serious Adverse Events (SAEs)
- Incidence of TEAEs and SAEs leading to discontinuation of study medication