To Evaluate the Safety/Tolerability and Pharmacokinetic Characteristics in Healthy Volunteers

JW Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo of JW2286; Drug: JW2286

Study type: Interventional

Funder types: Industry

Identifiers

NCT06703710

JW23104

Details and patient eligibility

About

This clinical trial is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 clinical trial to evaluate the safety/tolerability and pharmacokinetic characteristics, and to explore food effect and ethnic difference of JW2286 after oral administration in healthy adults.

Enrollment: 72 estimated patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Korean or Caucasian volunteers

Exclusion criteria

• Individuals with a clinically significant disease or history
• Individuals with a history of a gastrointestinal disorder or surgery
• In the case of all female individuals with childbearing potential, except for those who are surgically sterile

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

72 participants in 2 patient groups, including a placebo group

Test group (JW2286)

Experimental group

Description:

Ethnicity: Korean or Caucasian

Treatment:

Drug: JW2286

Placebo group (Placebo of JW2286)

Placebo Comparator group

Description:

Ethnicity: Korean or Caucasian

Treatment:

Drug: Placebo of JW2286