drugset / Trial / NCT04018170
Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JW1601 | Unknown | 10 mg | Oral |
| Subject | JW1601 | Unknown | 600 mg | Oral |
Indications
No indication recorded.