drugset
drugset / Trial / NCT03949426

Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects

NCT03949426 ↗

Phase 1 Completed 40 enrolled Kangpu Biopharmaceuticals, Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818. The study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in healthy participants and participants with systemic lupus erythematosus (SLE).

Timeline

Start
2019-05-01
Primary completion
2019-09-29
Completion
2019-09-29

Drugs

EvaluationDrugModalityDoseRoute
Subject KPG-818 Unknown 2 mg Oral
Subject KPG-818 Unknown 5 mg Oral
Subject KPG-818 Unknown 10 mg Oral
Subject KPG-818 Unknown 20 mg Oral
Subject KPG-818 Unknown 30 mg Oral

Indications

systemic lupus erythematosus