drugset / Trial / NCT04894071

QA102 Phase 1 Study in Healthy Young and Older Adult Subjects

NCT04894071 ↗

Phase 1 Completed 69 enrolled Smilebiotek Zhuhai Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2021-05-17
Primary completion
2021-11-15
Completion
2021-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject QA102 Unknown 50 mg Oral
Subject QA102 Unknown 100 mg Oral
Subject QA102 Unknown 200 mg Oral
Subject QA102 Unknown 400 mg Oral
Subject QA102 Unknown 800 mg Oral
Subject QA102 Unknown 1600 mg Oral