Single Ascending DosePhase 1NCT07190716
A Study to Evaluate the Safety of GR2301 Injection in Healthy Volunteers.
A Phase 1 study testing GR2301 injection in people with Single Ascending Dose and Healthy Subjects, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Single Ascending Dose, Healthy Subjects
- What is being tested?
- GR2301 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 30 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality
Assistant project manager, 15811002557, hanxiaolei@genrixbio.com
chun Lai Lu, Ph.D
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Pharmacodynamic Characteristics of a Single Dose of GR2301 Injection in Healthy Adult Subjects in China.
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.
- Conditions
- Single Ascending Dose, Healthy Subjects
- Being tested
- GR2301 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR2301 injectionBiological
IL15 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| GR2301 injection 1 | Experimental | GR2301 injection dose 1/Placebo，Subcutaneous Receives: Biological: GR2301 injection |
| GR2301 injection 2 | Experimental | GR2301 injection dose 2/Placebo，Subcutaneous Receives: Biological: GR2301 injection |
| GR2301 injection 3 | Experimental | GR2301 injection dose 3/Placebo，Subcutaneous Receives: Biological: GR2301 injection |
| GR2301 injection 4 | Experimental | GR2301 injection dose 4/Placebo，Subcutaneous Receives: Biological: GR2301 injection |
| GR2301 injection 5 | Experimental | GR2301 injection dose 5/Placebo，Subcutaneous Receives: Biological: GR2301 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Incidence of AEs
Measured: up to week16
Secondary outcomes (2)
Pharmacokinetics parameters
concentration of GR2301
Measured: up to week16
Incidence of ADA.
Measured: up to week16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Ascending DoseStudies of the same condition, open and under way.
- More trials run by Genrix (Shanghai) Biopharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190716
- Sponsor's protocol ID
- GR2301-001
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Pharmacodynamic Characteristics of a Single Dose of GR2301 Injection in Healthy Adult Subjects in China.
- ClinicalTrials.gov ID
- NCT07190716
- Acronym / sponsor ID
- GR2301-001
- Conditions
- Single Ascending Dose, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GR2301 injection 1 | Experimental | Biological: GR2301 injectionGR2301 injection dose 1/Placebo，Subcutaneous |
| GR2301 injection 2 | Experimental | Biological: GR2301 injectionGR2301 injection dose 2/Placebo，Subcutaneous |
| GR2301 injection 3 | Experimental | Biological: GR2301 injectionGR2301 injection dose 3/Placebo，Subcutaneous |
| GR2301 injection 4 | Experimental | Biological: GR2301 injectionGR2301 injection dose 4/Placebo，Subcutaneous |
| GR2301 injection 5 | Experimental | Biological: GR2301 injectionGR2301 injection dose 5/Placebo，Subcutaneous |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GR2301 injectionIL15 monoclonal antibody | Biological | GR2301 injection 1, GR2301 injection 2, GR2301 injection 3, GR2301 injection 4, GR2301 injection 5 |
Primary outcome
Adverse events (AEs)
Time frame: up to week16
Incidence of AEs
2 secondary outcomes
Pharmacokinetics parameters
Time frame: up to week16
Incidence of ADA.
Time frame: up to week16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GR2301 injection in people with Single Ascending Dose and Healthy Subjects, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact liaison officer (18233161126, shuxueye@genrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: up to week16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.