NCT07647224

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

May 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

June 15, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 24, 2026

Last Update Submit

June 9, 2026

Conditions

Multiple DoseHealthy Adult Participants

Keywords

IL15

Outcome Measures

Primary Outcomes (1)

  • Adverse events (AEs)

    Incidence of AEs

    Up to 52 Weeks

Secondary Outcomes (2)

  • Pharmacokinetics parameters

    Up to 52 weeks

  • Incidence of ADA.

    Up to 52 weeks

Study Arms (3)

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

GR2301 injectionDRUG

IL15 monoclonal antibody

GR2301 injection dose1/PlaceboGR2301 injection dose2/PlaceboGR2301 injection dose3/Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Central Study Contacts

liaison officer

CONTACT

021-50805988-8039shuxueye@genrixbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

June 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)