Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose of IBI3002 in Patients With Asthma - a Randomized, Double-Blind, Placebo-Controlled Study

A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma (NCT07015749) is a Phase 1 interventional studying Asthma, sponsored by The First Affiliated Hospital of Soochow University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 multiple doses in participants with asthma. The study plans to enroll participants with asthma on stable inhaled treatment, FeNO≥25ppb at screening and randomization, elevated peripheral blood eosinophils and Pre-BD FEV1 ≤ 80% of the prediction. The safety, tolerability, PK, immunogenicity and changes in PD and clinical characteristics of multiple doses of IBI3002 in asthma subjects will be evaluated. The entire study includes the screening period (4 weeks before dosing), the treatment period (12 weeks), and the safety follow-up period (8 weeks). The study plans to enroll 9 to 27 participants with asthma, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants will remain blind within the cohort. Cohort 1: 150mg SC(IBI3002: placebo =2 :1); Cohort 2: 300mg SC(IBI3002: placebo =2 :1); Cohort 3: 600mg SC(IBI3002: placebo =2 :1); The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.

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 Asthma, 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.

With a target enrollment of 12 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Aged between 18 and 65 years old (inclusive). 2. Weight ≥40kg. 3. Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator. 4. Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator. 5. FeNO ≥25ppb at screening and randomization. 6. Elevated peripheral blood eosinophils, defined as ≥300/μL in within 6 months prior to screening; OR ≥150/μL at screening. 7. Pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV) ≤ 80% of prediction. Who Should NOT Join This Trial: 1. Co-exsiting diseases that may have an impact on the participant's own safety or participation in the study, in the opinion of the Investigator. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system. 2. A known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first administration until the end of the study. 3. The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value at screening or randomization. 4. Experience of life-threatening asthma attacks requiring mechanical ventilation and/or asthma attacks related to hypercapnia, respiratory failure or hypoxic epilepsy within the 5 years prior to randomization. 5. History of other lung diseases besides asthma, including but not limited to chronic obstructive pulmonary disease, interstitial lung disease, etc, in the opinion of the Investigator. ...See full criteria on ClinicalTrials.gov 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: 1. Aged between 18 and 65 years old (inclusive). 2. Weight ≥40kg. 3. Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator. 4. Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator. 5. FeNO ≥25ppb at screening and randomization. 6. Elevated peripheral blood eosinophils, defined as ≥300/μL in within 6 months prior to screening; OR ≥150/μL at screening. 7. Pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV) ≤ 80% of prediction. Exclusion Criteria: 1. Co-exsiting diseases that may have an impact on the participant's own safety or participation in the study, in the opinion of the Investigator. Including but not limited to mental disorders, diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system or metabolic system. 2. A known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); Or chest imaging suggests the existence of suspected evidence of tuberculosis. Those with positive T-SPOT.TB need to receive preventive anti-tuberculosis treatment from 4 weeks before the first administration until the end of the study. 3. The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value at screening or randomization. 4. Experience of life-threatening asthma attacks requiring mechanical ventilation and/or asthma attacks related to hypercapnia, respiratory failure or hypoxic epilepsy within the 5 years prior to randomization. 5. History of other lung diseases besides asthma, including but not limited to chronic obstructive pulmonary disease, interstitial lung disease, etc, in the opinion of the Investigator. The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.

Treatments Being Tested

DRUG

Placebo

Participants with asthma will receive Placebo at the corresponding dose and dosing interval.

DRUG

IBI3002

Participants with asthma will receive IBI3002 at the corresponding dose and dosing interval.

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 (NCT07015749), the sponsor (The First Affiliated Hospital of Soochow University), 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 NCT07015749 clinical trial studying?

Who can participate in NCT07015749?

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 NCT07015749?

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.

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Source: ClinicalTrials.gov API v2 record for NCT07015749. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07015749. 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 2026-06-26 · Data from ClinicalTrials.gov.