The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Location status: Recruiting
NCT Number: NCT07015749
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Suzhou, Jiangsu, 215000, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a participant's potential participation in this trial.
Participants with asthma will receive Placebo at the corresponding dose and dosing interval.
Participants with asthma will receive IBI3002 at the corresponding dose and dosing interval.
Time frame: Baseline to Week 20
The incidence of Adverse events (AE) and Serious Adverse events (SAE) in participants with asthma after multiple administrations of IBI3002;
Time frame: Baseline to Week 20
PK parameters include, the maximum concentration (Cmax), after multiple doses.
Time frame: Baseline to Week 20
PK parameters include, the maximum concentration (Tmax), after multiple doses.
Time frame: Baseline to Week 20
PK parameters include, the maximum concentration (AUC), after multiple doses.
Time frame: Baseline to Week 20
PK parameters include the trough concentration (Cmin) after multiple doses.
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital of Soochow University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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