ClinicalTrials.gg
Not yet recruitingNCT07647224Updated Jun 15, 2026

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

A Phase 1 interventional study of GR2301 injection in Multiple Dose and Healthy Adult Participants, 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 2026-06-15.

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

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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 and immunogenicity characteristics of GR2301 injection in healthy adult subjects in China. The Multiple doses will be gradually escalated.

02

Conditions studied

  • Multiple Dose
  • Healthy Adult Participants

Keywords

  • IL15
03

In context

Lead sponsor

Genrix (Shanghai) Biopharmaceutical Co., Ltd. is the lead sponsor of 28 studies on the registry; 17 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. 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • Experimental
    GR2301 injection dose1/Placebo

    Drug: GR2301 injection

  • Experimental
    GR2301 injection dose2/Placebo

    Drug: GR2301 injection

  • Experimental
    GR2301 injection dose3/Placebo

    Drug: GR2301 injection

Interventions

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Incidence of AEs

    Time frame: Up to 52 Weeks

Secondary outcomes

  1. Pharmacokinetics parameters

    concentration of GR2301

    Time frame: Up to 52 weeks

  2. Incidence of ADA.

    Time frame: Up to 52 weeks

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2026; primary completion for Jul 2027, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 24, 2026
First posted
Jun 15, 2026
StartEst.
Jun 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07647224
Responsible party
Sponsor
First posted
Jun 15, 2026
Start date
Jun 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Jun 15, 2026

Study contacts

liaison officer
Contact
shuxueye@genrixbio.com
021-50805988-8039

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 May 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: GR2301

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