drugset / Trial / NCT04018170

Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

NCT04018170 ↗

Phase 1 Completed 102 enrolled JW Pharmaceutical
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is conducted to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean, Caucasian and Japanese adult volunteers

Timeline

Start
2019-02-15
Primary completion
2019-12-15
Completion
2019-12-15

Outcome

Met primary endpoint

release “아토피피부염 치료제 JW1601 국내 임상 1상 결과 보고서 도출 -히스타민 H4 수용체 타깃 혁신신약(First-in-Class) 후보물질로 안전성 입증” jw-pharma.co.kr ↗

release “임상결과에 따르면 최대 내약 용량을 결정하는 ‘용량증량 코호트 연구’에서 임상시험 계획 5단계까지 안전성과 내약성을 확인했다.” jw-pharma.co.kr ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject JW1601 Unknown 10 mg Oral
Subject JW1601 Unknown 600 mg Oral

Indications

No indication recorded.