Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers

NCT04018170 | Completed Phase 1 DMC

• 1 other identifier: JWP-FRC-101
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring

  AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.

  From Day 1 through Post Study Visit (Day 8)

• Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring

  AE incidence and the value or the change from baseline such as vital signs, 12-lead ECG, and clinical laboratory tests will be compared by each group and placebo group.

  From Day 1 through Post Study Visit (Day 14)

Secondary Outcomes (10)

• Cmax in plasma in single ascending dose administration

  Baseline(Day 1) through Day 4

• Tmax in plasma in single ascending dose administration

  Baseline(Day 1) through Day 4

• AUClast in plasma in single ascending dose administration

  Baseline(Day 1) through Day 4

• Eosinophil shape change(%) in single ascending dose administration

  Baseline(Day -1) through Day 4

• QT/QTc changes in single ascending dose administration

  Baseline(Day -1), Day 1, Day 2

Study Arms (2)

JW1601

EXPERIMENTAL

tablet formulation

Drug: Study drug

Placebo

PLACEBO COMPARATOR

tablet formulation identified with JW1601

Drug: Placebo

Interventions

Study drug DRUG

oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg

Also known as: JW1601

JW1601

Placebo DRUG

oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets

Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (2)

Severance Hospital

Seoul, 06725, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Officials

• Minsoo Park, MD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: July 12, 2019
• Study Start: February 15, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)