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Not yet recruitingNCT07190716Updated Sep 24, 2025

A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.

A Phase 1 interventional study of GR2301 injection in Single Ascending Dose and Healthy Subjects, sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.

02

Conditions studied

  • Single Ascending Dose
  • Healthy Subjects
03

In context

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 27 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Main Inclusion Criteria:

  1. BMI 19.0-28.0 kg/m², with male subjects weighing ≥50.0 kg and female subjects weighing ≥45.0 kg；
  2. 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:

  1. 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.
  2. History of drug use or substance abuse, or positive urine drug screening prior to enrollment.
  3. Pregnant and breastfeeding women.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    GR2301 injection 1

    GR2301 injection dose 1/Placebo，Subcutaneous

    Biological: GR2301 injection

  • Experimental
    GR2301 injection 2

    GR2301 injection dose 2/Placebo，Subcutaneous

    Biological: GR2301 injection

  • Experimental
    GR2301 injection 3

    GR2301 injection dose 3/Placebo，Subcutaneous

    Biological: GR2301 injection

  • Experimental
    GR2301 injection 4

    GR2301 injection dose 4/Placebo，Subcutaneous

    Biological: GR2301 injection

  • Experimental
    GR2301 injection 5

    GR2301 injection dose 5/Placebo，Subcutaneous

    Biological: GR2301 injection

Interventions

  • BiologicalGR2301 injection

    IL15 monoclonal antibody

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Incidence of AEs

    Time frame: up to week16

Secondary outcomes

  1. Pharmacokinetics parameters

    concentration of GR2301

    Time frame: up to week16

  2. Incidence of ADA.

    Time frame: up to week16

07

Study locations

1 site
  • Beijing Tongren Hospital Affiliated to Capital Medical University
    Beijing, Beijing Municipality, China
    • Assistant project manager · Contact · hanxiaolei@genrixbio.com · 15811002557
    • chun Lai Lu, Ph.D · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07190716
Lead sponsor
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 24, 2025
Start date
Oct 10, 2025 (estimated)
Primary completion
May 30, 2026 (estimated)
Completion
May 30, 2026 (estimated)
Last update
Sep 24, 2025

Study contacts

liaison officer
Contact
shuxueye@genrixbio.com
18233161126

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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