NCT06378684

Brief Summary

The objective is to evaluate the safety and Pharmacokinetic Interactions after adminitration drug(Treatment A or B or A+B) in Healthy Volunteers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

March 29, 2024

Last Update Submit

April 18, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

    Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

  • AUCτ,ss

    Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

    Day 1(0 hour), Day 8(0 hour), Day 9(0 hour), Day 10(0 hour) ~ Day 13(72 hours)

Study Arms (6)

Group 1

OTHER

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Drug: Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)

Group 2

OTHER

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Drug: Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)

Group 3

OTHER

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Drug: Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)

Group 4

OTHER

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Drug: Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)

Group 5

OTHER

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Drug: Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)

Group 6

OTHER

Treatment A: administration of 1 tablet of JW0104 Treatment B: administration of 1 tablet of C2207 Treatment A+B: Co-administration of 2 tablets of JW0104 and C2207 Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Drug: Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)

Interventions

Group 1: JW0104(Period 1), C2207(Period 2), JW0104 + C2207(Period 3)DRUG

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 1
Group 2: JW0104 + C2207(Period 1), JW0104(Period 2), C2207(Period 3)DRUG

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 2
Group 3: C2207(Period 1), JW0104 + C2207(Period 2), JW0104(Period 3)DRUG

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 3
Group 4: JW0104(Period 1), JW0104 + C2207(Period 2), C2207(Period 3)DRUG

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 4
Group 5: JW0104 + C2207(Period 1), C2207(Period 2), JW0104(Period 3)DRUG

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 5
Group 6: C2207(Period 1), JW0104(Period 2), JW0104 + C2207(Period 3)DRUG

Tablet, Oral, QD for 10 Days, Washout period is more than 14 days after administration

Group 6

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Severance Hospital

Seoul, South Korea

Location

Study Officials

  • MinSoo Kim

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 22, 2024

Study Start

September 10, 2023

Primary Completion

December 23, 2023

Study Completion

January 13, 2024

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)