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

NCT ID: NCT07015749

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2026-05-20

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IBI3002 600mg SC

Participants with asthma will receive IBI3002 600mg SC

Group Type: EXPERIMENTAL

IBI3002

Intervention Type: DRUG

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

IBI3002 150mg SC

Participants with asthma will receive IBI3002 150mg SC

Group Type: EXPERIMENTAL

IBI3002

Intervention Type: DRUG

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

Placebo 4ml SC

Participants with asthma will receive Placebo 4ml SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Placebo 1ml SC

Participants with asthma will receive Placebo 1ml SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Placebo 2ml SC

Participants with asthma will receive Placebo 2ml SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

IBI3002 300mg SC

Participants with asthma will receive IBI3002 300mg SC

Group Type: EXPERIMENTAL

IBI3002

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

IBI3002

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wensheng Zang

Role: CONTACT

wensheng.zang@innoventbio.com

15210342569

Facility Contacts

Wei Lei

Role: primary

leiweilw@suda.edu.cn

13771899249

Other Identifiers

CIBI3002T001

Identifier Type: -

Identifier Source: org_study_id