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A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

NCT05354336 ↗

Phase 1 Completed 36 enrolled The Affiliated Hospital of Qingdao University
RandomizedParallel-groupOpen-labelTreatment

Summary

This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.

Timeline

Start
2019-06-13
Primary completion
2019-08-24
Completion
2019-08-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule 100 mg Oral
Subject Dalpiciclib Small molecule 125 mg Oral
Subject Dalpiciclib Small molecule 150 mg Oral

Indications

No indication recorded.