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Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

NCT04018170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-02-13

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Minsoo Park, MD · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018170 on ClinicalTrials.gov