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Tests treatment safety and results for Asthma
Official title A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Asthma
ClinicalTrials.gov ID: NCT07015749
What this study is testing
What is IBI3002?
IBI3002 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Aged between 18 and 65 years old (inclusive).
- Weight ≥40kg.
- Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
- Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator.
- FeNO ≥25ppb at screening and randomization.
You likely can't join if
- 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...
- A known history of active tuberculosis or clinically suspected manifestations of tuberculosis (including but not limited to pulmonary tuberculosis...
- The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value at screening or randomization.
- Experience of life-threatening asthma attacks requiring mechanical ventilation and/or asthma attacks related to hypercapnia, respiratory failure or...
- History of other lung diseases besides asthma, including but not limited to chronic obstructive pulmonary disease, interstitial lung disease, etc, in...
See the full eligibility criteria
- Aged between 18 and 65 years old (inclusive).
- Weight ≥40kg.
- Diagnosed with Asthma for ≥12 months in accordance with the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
- Receiving inhaled treatment with or without inhaled corticosteroids (ICS), which has been stablized for ≥ 1 month and confirmed by the Investigator.
- FeNO ≥25ppb at screening and randomization.
- Elevated peripheral blood eosinophils, defined as ≥300/μL in within 6 months prior to screening; OR ≥150/μL at screening.
- Pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV) ≤ 80% of prediction.
- 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...
- 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...
- The peripheral blood white blood cells or neutrophils are lower than the lower limit of the normal value at screening or randomization.
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.