An Exploratory Clinical Study Evaluating EPI-003 Injectio... | NCT06745973

Studies
An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

NCT06745973

Sponsor

Epigenic Therapeutics, Inc

Status

Not yet recruiting

Last Update Posted

Dec 24, 2024Actual

Enrollment

20Estimated

Phase

Early Phase 1

Conditions

Chronic Hepatitis B

Interventions

EPI-003

Countries

China

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

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2024Estimated

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 9, 2024

First Submission Date that Met QC Criteria

Dec 18, 2024

First Posted Date

Dec 24, 2024Actual

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

Dec 18, 2024

Last Update Posted Date

Dec 24, 2024Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself.

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

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
EPI-003	Experimental		Drug: EPI-003

Name	Type	Description	Arm Group Labels	Other Names
EPI-003	Drug	Intravenous (IV) infusion.	EPI-003

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs		From Baseline through to Day 28 postdose

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of maximum observed concentration (Cmax)		From Baseline through to Day 28 postdose
Evaluation of maximum observed concentration (tmax)		From Baseline through to Day 28 postdose

Other Outcomes

Measure	Description	Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).		From Baseline through to Day 365 postdose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
Confirmed diagnosis of CHB;
Received a stable dose of NA therapy for ≥ 6 months prior to screening and plan to continue receiving the same dose for the duration of the study

Exclusion Criteria:

Confirmed diagnosis of liver cancer or cirrhosis;
Combination of other major diseases; 3 Pregnant or lactating females.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Feng Epigenic Therapeutics Clinical Trials	Contact	86-17621694653		clinical@epigenictx.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Renji Hospital, Shanghai Jiao Tong University School of Medicine		Shanghai			China

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

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided