A dose block-randomized, double-blind, placebo-controlled, single and multiple ascending dose, phase I clinical trial to evaluate the safety/tolerability and PK/PD of JW1601 after oral administration in healthy Korean and Caucasian adults
2019-06-14 358

With this clinical study, we intend to evaluate the safety, pharmacodynamics, and pharmacokinetic and pharmacodynamics characteristics of JW1601 after a single dose intake.

- Healthy males and females between 19 and 55 years of age at the time of signing the informed consent - Body weight: ≥55 kg for men and ≥50 kg for women - BMI between 18.5 kg/m2 and 28.0 kg/m2 - If female, post-menopausal (i.e., no menstruation for at least 2 years or being in a menopause state) - Those who have not participated in any other clinical studies for the past three months (including bioequivalence studies). - Those who have not donated blood within 60 days prior to the participation of this clinical study. - Able and willing to complete the informed consent process - Available for clinical follow-up through the last study visit

- JW1601 10 mg, 100 mg, 150 mg - Placebo matching with JW1601 10 mg, 100 mg, 150 mg

Group1 Planned dates*
Screening Visit 2019-08-05
Hospitalization (6 days/5 nights) 2019-08-22 ~ 2019-07-27
Outpatient visit 2019-08-21
Group 2 After Group 1 is completed; most likely in September 2019
Group 3 After Group 2 is completed; most likely in October 2019
* Please contact us, for schedule and allocation into a group may be arranged as needed.

You may receive a certain amount of monetary compensation for your participation. The compensation will be different depending on the duration and complexity of study participation. (No compensation for participating on the screening test only.)

2019-06-14 ~ 2019-10-31



For more detailed information on this study, please contact the Clinical Trials Center, Severance Hospital, Yonsei University Health System (Investigator: Xue Meng, 02-2228-0462, lynnmeng@yuhs.ac) between 09:30 A.M and 05:30 P.M., from Monday to Friday. (한국인 대상자는 모집하지 않습니다.)