Health Adult SubjectsPhase 1NCT07199270
A Study to Evaluate the Safety, Immunogenicity, and Pharmacokinetics of GR2303 in Healthy Adult
A Phase 1 study testing GR2303 injection in people with Health Adult Subjects, run by Genrix (Shanghai) Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Adult Subjects
- What is being tested?
- GR2303 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2025to 16 Dec 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
Who may be able to join
- Healthy adult subjects
- Signed informed consent
Who cannot join
- History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- Prior use of drug targeting TNF-like cytokine 1A
- history of malignant tumor
- psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
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, 1 recruiting
- Recruiting
Beijing Friendship hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Professor Dong, 010-63139003, Ruihua_Dong_RW@163.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups
Read the detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.
- Conditions
- Health Adult Subjects
- Being tested
- GR2303 injection, Placebo
- Keywords
- Inflamatory bowel disease, phase 1, GR2303
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR2303 injectionBiological
single dose
PlaceboBiological
single dose
GR2303 injectionBiological
multiple dose
PlaceboBiological
multiple dose
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | single dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 2 | Experimental | single dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 3 | Experimental | single dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 4 | Experimental | single dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 5 | Experimental | single dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 6 | Experimental | multiple dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 7 | Experimental | multiple dose Receives: Biological: GR2303 injection; Biological: Placebo |
| group 8 | Experimental | multiple dose Receives: Biological: GR2303 injection; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: 16 weeks
Secondary outcomes (4)
Cmax
Measured: 16 weeks
Tmax
Measured: 16 weeks
t 1/2
Measured: 16 weeks
ADA
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start18 Sep 2025
- Primary completion18 Sep 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Adult SubjectsStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT07199270
- Sponsor's protocol ID
- GR2303-001
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled of GR2303 Injection in Healthy Adult Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacologic of GR2303
- ClinicalTrials.gov ID
- NCT07199270
- Acronym / sponsor ID
- GR2303-001
- Conditions
- Health Adult Subjects
- Keywords
- Inflamatory bowel disease, phase 1, GR2303
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 18 Sep 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 30 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.
he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups
Detailed description
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: GR2303 injection, Biological: Placebosingle dose |
| group 2 | Experimental | Biological: GR2303 injection, Biological: Placebosingle dose |
| group 3 | Experimental | Biological: GR2303 injection, Biological: Placebosingle dose |
| group 4 | Experimental | Biological: GR2303 injection, Biological: Placebosingle dose |
| group 5 | Experimental | Biological: GR2303 injection, Biological: Placebosingle dose |
| group 6 | Experimental | Biological: GR2303 injection, Biological: Placebomultiple dose |
| group 7 | Experimental | Biological: GR2303 injection, Biological: Placebomultiple dose |
| group 8 | Experimental | Biological: GR2303 injection, Biological: Placebomultiple dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adult subjects
- Signed informed consent
Key exclusion criteria (4 listed)
- History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.
- Prior use of drug targeting TNF-like cytokine 1A
- history of malignant tumor
- psitive results for Hepatitis B surface antigen (HBsAg), anti Hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| GR2303 injectionsingle dose | Biological | group 1, group 2, group 3, group 4, group 5 |
| Placebosingle dose | Biological | group 1, group 2, group 3, group 4, group 5 |
| GR2303 injectionmultiple dose | Biological | group 6, group 7, group 8 |
| Placebomultiple dose | Biological | group 6, group 7, group 8 |
Primary outcome
Adverse events
Time frame: 16 weeks
4 secondary outcomes
Cmax
Time frame: 16 weeks
Tmax
Time frame: 16 weeks
t 1/2
Time frame: 16 weeks
ADA
Time frame: 16 weeks
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 30 Sep 2025.
- Individual participant dataSharing planned: No
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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 GR2303 injection in people with Health Adult 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?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 30 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 Nian (021-50805989-08324, nianhanli@genrixbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 16 weeks). 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 30 Sep 2025.