A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011

A Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anti-IL-RAP Humanized Monoclonal Antibody Injection in Chinese Subjects

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic of IBI3011 (NCT07295496) is a Phase 1 interventional studying Acute Gout Flare, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Acute Gout Flare, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Acute Gout Flare subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Subjects are eligible for the study if they meet all of the following Who May Qualify: 1. Age ≥18 years of age, male or female; 2. 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 3. Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout; 4. Other inclusion criteria set by protocol Who Should NOT Join This Trial: Subjects meeting any of the following criteria are not eligible to attend this clinical study: 1. Difficulties in venous blood collection or a history of dizziness when encountering blood or needles; 2. Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior; 3. Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial; 4. Blood donation or blood loss of more than 400 mL within 8 weeks before the screening; 5. Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening; 6. History of malignancy; 7. Female during pregnancy or lactation; 8. Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening; 9. 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: 10. Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout); 11. Infection/septic arthritis, or other acute inflammatory arthritis; 12. Other exclusion criteria set by protocol Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Subjects are eligible for the study if they meet all of the following Inclusion Criteria: 1. Age ≥18 years of age, male or female; 2. 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 3. Meet ACR 2015 preliminary criteria for the classification of acute arthritis of primary gout; 4. Other inclusion criteria set by protocol Exclusion Criteria: Subjects meeting any of the following criteria are not eligible to attend this clinical study: 1. Difficulties in venous blood collection or a history of dizziness when encountering blood or needles; 2. Have received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior; 3. Have live or attenuated vaccination in the 3 months before randomization or plan to receive that during this trial; 4. Blood donation or blood loss of more than 400 mL within 8 weeks before the screening; 5. Have a history of severe infection, severe trauma, or major surgical procedures within 6 months before the screening; 6. History of malignancy; 7. Female during pregnancy or lactation; 8. Have a history of drug abuse, drug dependence, or a positive result in a drug screen within 12 months before the screening; 9. 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: 10. Secondary gout (e.g., gout induced by chemotherapy, transplant-related gout); 11. Infection/septic arthritis, or other acute inflammatory arthritis; 12. Other exclusion criteria set by protocol

Treatments Being Tested

DRUG

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 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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07295496), the sponsor (Innovent Biologics (Suzhou) Co. Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07295496 clinical trial studying?

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) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07295496?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07295496?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07295496. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07295496. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.