Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

JW Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Study drug; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04018170

JWP-FRC-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who have voluntarily given written informed consent to participate in the study and comply with all study requirements after getting detailed explanation and full understanding of the study

Exclusion criteria

• Subjects judged by the investigators unsuitable for participating in the study based on any other reasons

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

102 participants in 2 patient groups, including a placebo group

JW1601

Experimental group

Description:

tablet formulation

Treatment:

Drug: Study drug

Placebo

Placebo Comparator group

Description:

tablet formulation identified with JW1601

Treatment:

Drug: Placebo