NCT06754943

Brief Summary

The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0104 and C2402 and administration of JW0105 in healthy volunteers under fasting conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jan 2025

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

First Submitted

Initial submission to the registry

December 10, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

December 10, 2024

Last Update Submit

September 2, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Plasma concentrations are measured using a validated LC-MS/MS.

    Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4

  • Cmax

    Plasma concentrations are measured using a validated LC-MS/MS.

    Day 1 (0 hour) ~ Day 3 (72 hour) post-dose in period 1, period 2, period 3, and period 4

Study Arms (2)

Group 1

OTHER

* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105

Drug: Treatment A_Period 1Drug: Treatment B_Period 2Drug: Treatment A_Period 3Drug: Treatment B_Period 4

Group 2

OTHER

* Treatment A: Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Treatment B: Administration alone of 1 tablet of JW0105

Drug: Treatment B_Period 1Drug: Treatment A_Period 2Drug: Treatment B_Period 3Drug: Treatment A_Period 4

Interventions

Treatment A_Period 1DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 1
Treatment B_Period 2DRUG

* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 1
Treatment A_Period 3DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 1
Treatment B_Period 4DRUG

* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 1
Treatment B_Period 1DRUG

* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 2
Treatment A_Period 2DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 2
Treatment B_Period 3DRUG

* Administration alone of 1 tablet of JW0105 * Wash-out period: 21 days * Administration: Treatment B is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 2
Treatment A_Period 4DRUG

* Co-administration of 1 tablet of JW0104 and 1 tablet of C2402 * Wash-out period: 21 days * Administration: Treatment A is administered orally with 150 mL of water under fasting conditions

Also known as: NA (Not Applicable)
Group 2

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)

Metro Hospital

Anyang-si, Gyeonni-do, 14096, South Korea

Location

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Sung-Dae Kwon

    Metro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 10, 2024

First Posted

January 1, 2025

Study Start

January 17, 2025

Primary Completion

March 24, 2025

Study Completion

April 22, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)