Clinical trial NCT04018170: Single and Multiple Ascending Dose Study of JW1601 for Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-07-12
Enrollment: 102
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability after single ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
timeFrame: From Day 1 through Post Study Visit (Day 8)
measure: Safety and tolerability in multiple ascending dose administration based on laboratory values, vital signs, ECG, physical examinations and Adverse Events monitoring
timeFrame: From Day 1 through Post Study Visit (Day 14)
Secondary outcomes:
measure: Cmax in plasma in single ascending dose administration
timeFrame: Baseline(Day 1) through Day 4
measure: Tmax in plasma in single ascending dose administration
timeFrame: Baseline(Day 1) through Day 4
measure: AUClast in plasma in single ascending dose administration
timeFrame: Baseline(Day 1) through Day 4
measure: Eosinophil shape change(%) in single ascending dose administration
timeFrame: Baseline(Day -1) through Day 4
measure: QT/QTc changes in single ascending dose administration
timeFrame: Baseline(Day -1), Day 1, Day 2
measure: C(max, ss) in plasma in multiple ascending dose administration
timeFrame: Baseline(Day 1) through Day 10
measure: T(max,ss) in plasma in multiple ascending dose administration
timeFrame: Baseline(Day 1) through Day 10
measure: AUC(τ,ss) in plasma in multiple ascending dose administration
timeFrame: Baseline(Day 1) through Day 10
measure: Eosinophil shape change(%) in multiple ascending dose administration
timeFrame: Baseline(Day -1) through Day 10
measure: QT/QTc changes in multiple ascending dose administration
timeFrame: Baseline(Day -1), Day 7, Day 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Severance Hospital
name: Minsoo Park, MD
role: PRINCIPAL_INVESTIGATOR
References: