A Clinical Trial of Multiple Doses of GR2301 Injection in... | NCT07647224

Studies
A Clinical Trial of Multiple Doses of GR2301 Injection in Healthy Adult Trial Participants in China.

NCT07647224

Sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Jun 15, 2026Actual

Enrollment

36Estimated

Phase

Phase 1

Conditions

Multiple Dose
Healthy Adult Participants

Interventions

GR2301 injection

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

May 2026

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

Jun 2026Estimated

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

May 24, 2026

First Submission Date that Met QC Criteria

Jun 9, 2026

First Posted Date

Jun 15, 2026Actual

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

Jun 9, 2026

Last Update Posted Date

Jun 15, 2026Actual

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 is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and immunogenicity characteristics of GR2301 injection in healthy adult subjects in China. The Multiple doses will be gradually escalated.

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

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
GR2301 injection dose1/Placebo	Experimental	Drug: GR2301 injection
GR2301 injection dose2/Placebo	Experimental	Drug: GR2301 injection
GR2301 injection dose3/Placebo	Experimental	Drug: GR2301 injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GR2301 injection	Drug	IL15 monoclonal antibody	GR2301 injection dose1/Placebo GR2301 injection dose2/Placebo GR2301 injection dose3/Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events (AEs)	Incidence of AEs	Up to 52 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics parameters	concentration of GR2301	Up to 52 weeks
Incidence of ADA.		Up to 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

BMI 19.0-28.0 kg/m², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg；
Understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign the informed consent form.

Main Exclusion Criteria:

A history of past or current conditions involving the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, endocrine system, metabolic system, or other clearly documented medical conditions, which the investigator deems may pose a risk to the subject's safety or interfere with the conduct, progress, or completion of the trial.
History of drug use or substance abuse, or positive urine drug screening prior to enrollment.
Pregnant and breastfeeding women.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
liaison officer	Contact	021-50805988-8039		shuxueye@genrixbio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tongren Hospital Affiliated to Capital Medical University		Beijing	Beijing Municipality	100730	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