NCT04018170

Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

A Dose Block-randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, Phase I Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of JW1601

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: JW Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and PK/PD profile by administering investigational product (IP) as a single dose (One time) or repeated doses (7 days, once a day) orally in a fasted state.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Study drug	oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg
DRUG	Placebo	oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Timeline

• Start date: 2019-02-15
• Primary completion: 2019-12-15
• Completion: 2019-12-15
• First posted: 2019-07-12
• Last updated: 2020-02-13

Locations

2 sites across 1 country: South Korea