Acute Gout FlarePhase 1NCT07295496
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011
A Phase 1 study testing IBI3011 in people with Acute Gout Flare, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B) Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Gout Flare
- What is being tested?
- IBI3011
- 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
- 8 Dec 2025to 7 Jun 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are eligible for the study if they meet all of the following Inclusion Criteria:
- Age ≥18 years of age, male or female;
- Body mass index (BMI) 18-26 kg/m2 (inclusive) for Part A healthy subjects and BMI 18-40 kg/m2 (inclusive) for Part B acute gout flare subjects; Part B acute gout flare subjects also needed to meet the following criteria
- Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
- Other inclusion criteria set by protocol
Who cannot join
- Subjects meeting any of the following criteria are not eligible to attend this clinical study:
- Difficulties in venous blood collection or a history of dizziness when encountering blood or needles;
- Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
- Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial;
- Blood donation or blood loss of more than 400 mL within 8 weeks before the screening;
- Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening;
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- History of malignancy;
- Female during pregnancy or lactation;
- Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening;
- Has a history of neuropsychiatry or any other disease/ailment that is unsuitable for this clinical trial at the discretion of the Investigator;
- Part B acute gout flare subjects also needed to exclude the following criteria:
- Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout);
- Infection/septic arthritis, or other acute inflammatory arthritis;
- Other exclusion criteria set by protocol
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B)
- Conditions
- Acute Gout Flare
- Being tested
- IBI3011, IBI3011 Placebo
- Keywords
- acute gout flare
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3011Drug
- Anti-IL-RAP humanised monoclonal antibody injection
- 300 mg (2.0 mL)/vial
- Administered in accordance with the study protocol
- Single administration only
IBI3011 PlaceboDrug
- Anti-IL-RAP humanised monoclonal antibody placebo injection
- 300 mg (2.0 mL)/vial
- Administered in accordance with the study protocol
- Single administration only
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | IBI3011 placebo group Receives: Drug: IBI3011 Placebo |
| IBI3011 | Active comparator | IBI3011 group Receives: Drug: IBI3011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics.
Measured: 12 week
Secondary outcomes (6)
Immunogenic outcome
The incidence of antidrug Antibody (ADA) and/or Neutralising antibodies (NAb)
Measured: 12 week
AUC
Describing the Area Under Curve
Measured: 12 Week
Cmax
Describing the Maximum Serum Concentration of Drug
Measured: 12 Week
CL or CL/F
Describing the Clearance
Measured: 12 Week
V or V/F
Describing the Apparent Volume of Distribution
Measured: 12 Week
t1/2
Describing the Half Life
Measured: 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start8 Dec 2025
- Primary completion7 Jun 2026 (estimated)
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Gout FlareStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295496
- Sponsor's protocol ID
- CIBI3011A101
- Status last verified
- May 2026
- First submitted
- 24 Nov 2025
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects
- ClinicalTrials.gov ID
- NCT07295496
- Acronym / sponsor ID
- CIBI3011A101
- Conditions
- Acute Gout Flare
- Keywords
- acute gout flare
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 7 Jun 2026 (estimated)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 19 Dec 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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: IBI3011 PlaceboIBI3011 placebo group |
| IBI3011 | Active comparator | Drug: IBI3011IBI3011 group |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years of age, male or female;
- Body mass index (BMI) 18-26 kg/m2 (inclusive) for Part A healthy subjects and BMI 18-40 kg/m2 (inclusive) for Part B acute gout flare subjects; Part B acute gout flare subjects also needed to meet the following criteria
- Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout;
- Other inclusion criteria set by protocol
Key exclusion criteria (14 listed)
- Subjects meeting any of the following criteria are not eligible to attend this clinical study:
- Difficulties in venous blood collection or a history of dizziness when encountering blood or needles;
- Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior;
- Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial;
- Blood donation or blood loss of more than 400 mL within 8 weeks before the screening;
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 |
|---|---|---|
| IBI3011* Anti-IL-RAP humanised monoclonal antibody injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only | Drug | IBI3011 |
| IBI3011 Placebo* Anti-IL-RAP humanised monoclonal antibody placebo injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 12 week
To investigate the safety characteristics.
6 secondary outcomes
Immunogenic outcome
Time frame: 12 week
AUC
Time frame: 12 Week
Cmax
Time frame: 12 Week
CL or CL/F
Time frame: 12 Week
V or V/F
Time frame: 12 Week
t1/2
Time frame: 12 Week
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 27 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 IBI3011 in people with Acute Gout Flare, run by Innovent Biologics (Suzhou) 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 5 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 12 week). 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 27 May 2026.