PRG Science & Technology Co., Ltd.
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.
Subjects who have successfully completed the Screening phase will enter the baseline and treatment phase of the study. Subjects will take the assigned treatment of Progerinin (2400 mg) split as 1200 mg BID in the morning and evening with food for 1-Year. To evaluate the safety and tolerability of Progerinin for the treatment of BMD loss in subjects with typical Werner syndrome. The secondary objectives of this study are: * To characterize the activity of Progerinin on bone metabolism in subjects with typical Werner Syndrome. * To evaluate vascular function in subjects with typical Werner Sy…
\[Inclusion Criteria\] 1. Subjects must be at least ≥ 18 years of age. 2. Subjects should have a confirmed diagnosis of typical Werner syndrome by genetic analysis. 3. Subjects should be osteopenic (T-score between -1.0 and -2.5) or have confirmed osteoporosis (T-score ≤ -2.5) at screening/baseline. Subjects may continue to receive bone supplements (e.g., bisphosphonates, calcium supplements, Vitamin D supplements, etc.) as appropriate per standard of care throughout the study. 4. Male or non-pregnant, non-lactating female. 5. Subjects screening blood chemistry inclusive of metabolic panel, h…
This is a Phase 2, open-label study to evaluate the safety and Tolerability of Progerinin for the treatment of BMD 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. This study will have three phases: Screening Phase, Treatment Phase, and Follow-Up Phase.
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