A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthma… (NCT06947408) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Healthy and Asthmatic Participants
China44 participantsStarted 2025-05-14
Plain-language summary
This study is a randomized, double-blind, placebo-controlled multiple dose ascending study in healthy participants and patients with asthma. Healthy participants will be enrolled in Part A and patients with asthma in Part B:
1. Part A: 40 healthy participants will be enrolled across 5 cohorts, including 5 different dose levels. In each cohort, there will be 8 participants randomized at a ratio of 6:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 12 to 14 weeks.
2. Part B: 20 patients with asthma will be enrolled across 2 cohorts. In each cohort, there will be 10 participants randomized at a ratio of 8:2 to receive IBI3002 or matched placebo. The study consists of a screening period, a double-blind treatment period and a safety follow-up period. The study has a total duration of approximately 16 weeks.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. (Part A and B) The body weight of men ≥ 50kg, and of women ≥ 45kg; Body mass index (BMI) between 18 and 32 kg/m2 (including cut-off values).
. (Part B) Diagnosed with asthma for at least 12 months according to the Global Initiative for Asthma (GINA) and confirmed by the Investigator.
. (Part B) Evidence of airway reversibility within 5 years prior to screening, including but not limited to a positive bronchodilation test or bronchoprovocation test. If the historical results are not available, tests during the screening period will also be accepted.
. (Part B) Medium-high dose ICS therapy (defined as a daily dose of ≥250μg fluticasone propionate or equivalent ICS dose) in combination with at least one second controller \[e.g., LABA, LAMA, or LTRA for at least 3 months with a stable dose for at least 1 month prior to randomization.
. (Part B) Pre-BD FEV1 ≤ 80% of prediction.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since IBI3002 is a Phase 1 trial that focused on safety and tolerability rather than how well it treats asthma, what does that mean for what we actually know about whether it helps control my asthma symptoms?
2This trial has already completed — does my doctor know if the safety results from this study are available, and what kinds of adverse events were seen in the asthma participants specifically?
3Because Phase 1 trials are primarily designed to find safe dosing rather than prove effectiveness, would it make more sense for me to stick with my current asthma medications while we wait for Phase 2 or Phase 3 results on IBI3002?
4The trial enrolled both healthy people and people with asthma — does my doctor know whether the safety profile looked different between those two groups, and what that might mean for someone with my specific asthma history?
5Are there other ongoing or upcoming IBI3002 trials that my doctor thinks might be a better fit for my situation, now that this Phase 1 safety study has finished?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the Incidence of sudden adverse events of healthy participants and patients with asthma receiving IBI3002 multiple ascending doses.
. (Part A and B) Diseases that have an impact on the participant's own safety or participation in the study as judged by the investigator. This includes, 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.
. (Part A and B) Participants with known history of active tuberculosis or clinical suspicion of tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or positive T-SPOT.TB during the screening period, or evidence of suspected tuberculosis on chest imaging, or any other clinical evidence of latent tuberculosis.
. (Part A and B) A history of malignancy, except for localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin that has been resected or cured.
. (Part B) History of a life-threatening asthma attack requiring mechanical ventilation, and/or an asthma attack related to hypercapnia, respiratory failure, or hypoxic epilepsy within 5 years prior to screening.
. (Part B) History of an asthma worsening or exacerbation that resulted in an visit to emergency room or hospitalization, or an increase in asthma controller, or requiring any systemic glucocorticoid therapy within 3 months prior to screening.