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

NCT07015749 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2026-05-20
Completion
2026-05-20

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07015749 on ClinicalTrials.gov