Phase 1 Study of JLP-2302 and JP-1366: PK and Safety in H... | NCT07181538

Studies
Phase 1 Study of JLP-2302 and JP-1366: PK and Safety in Healthy Volunteers

NCT07181538

Sponsor

Onconic Therapeutics Inc.

Status

Completed

Last Update Posted

Sep 18, 2025Actual

Enrollment

55Actual

Phase

Phase 1

Conditions

Healthy

Interventions

JLP-2302
JP-1366

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 4, 2025Actual

Primary Completion Date

Feb 20, 2025Actual

Completion Date

Mar 5, 2025Actual

First Submitted Date

Aug 29, 2025

First Submission Date that Met QC Criteria

Sep 11, 2025

First Posted Date

Sep 18, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2025

Last Update Posted Date

Sep 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the pharmacokinetics and the safety after administration of "JLP-2302" and "JP-1366" in healthy volunteers.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JLP-2302 and JP-1366 crossover	Experimental		Drug: JLP-2302 Drug: JP-1366
JP-1366 and JLP-2302 crossover	Active Comparator		Drug: JLP-2302 Drug: JP-1366

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JLP-2302	Drug	taking JLP-2302	JLP-2302 and JP-1366 crossover JP-1366 and JLP-2302 crossover

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the plasma drug concentration-time curve(AUCt)		Pre-dose on Day 1 and on Days 2 post-dose
Peak Plasma Concentration (Cmax)		Pre-dose on Day 1 and on Days 2 post-dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with a body mass index (BMI) between 18.0 and 30.0 kg/m²
Subjects without any clinically significant congenital or chronic disease, and with no pathological findings based on medical examination
Subjects who agree to use a medically acceptable method of contraception*

Exclusion Criteria:

Subjects who have taken enzyme-inducing or -inhibiting drugs
Subjects who have participated in a bioequivalence or other clinical trial and received an investigational product within 6 months prior to the first dose
Subjects with a history of gastrointestinal surgery that may affect drug absorption
Subjects with a clinically significant history of psychiatric illness
Female subjects who are pregnant, suspected of being pregnant, or currently breastfeeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided