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QA102 Phase 1 Study in Healthy Young and Older Adult Subjects

Smilebiotek Zhuhai Limited · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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age-related-macular-degeneration
This will be a double masked, randomized, placebo controlled, single and multiple oral dose study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young and older adult subjects will be evaluated. The study will also characterize the pharmacokinetic (PK) profile of QA102 in plasma and urine after single and multiple oral doses of QA102. Besides, the metabolite profile of QA102 will also be characterized. Part 1 will comprise a single dose, sequential cohort design. Part 2 will comprise a multiple dose, sequential cohort study. Part 3 will comprise a multiple dose, single cohort study in older subjects.
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