A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Mode… (NCT06213844) | Clinical Trial Compass
CompletedPhase 1
A First-in-human, Single-ascending-dose Study of IBI3002 in Healthy Participants and Mild to Moderate Asthmatics
Australia52 participantsStarted 2024-02-26
Plain-language summary
This is a single-center, randomized, double-blind, placebo-controlled, phase 1, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of IBI3002 in healthy participants and mild to moderate asthmatics. Subjects will be randomly assigned to different dosages of IBI3002 and matched placebo groups. The entire trial cycle includes a 4-week screening period, 1-day treatment period and 5-week follow-up period.
Who can participate
Age range
18 Years – 55 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
. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedures.
. Participants must be between 18 and 55 years old, inclusive.
. Participants must have a body mass index (BMI) between 18 to 32 kg/m2, inclusive.
. Participants of childbearing potential and their partners should use highly effective methods of birth control during the study and until 6 months after the study.
. Participants with asthma must have:
Exclusion criteria
. History of allergies to any components of IBI3002 or placebo.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. History of blood or needle sickness, or those who cannot tolerate venipuncture.
. Female participants who are pregnant or breastfeeding at screening or randomization.
. History of participating in a clinical trial within 1 month or 5 half-lives of the test drug (whichever is longer) prior to randomization, or those who are currently participating in a clinical trial.
. History of severe infection or significant injury within 6 months, or surgery within 3 months, or any infection requiring systemic medication within 1 month prior to screening or randomization.
. History of live or attenuated vaccination within 1 month prior to randomization, or those who plan to be vaccinated during the study.
. For asthmatics only: history of a life-threatening asthma attack that required mechanical ventilation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years prior to randomization.
. For asthmatics only: history of asthma worsen or exacerbation resulting in emergency room (ER) visits or overnight hospitalizations, or an increase in asthma maintenance therapy, or use of systemic glucocorticoids within the last 3 months prior to randomization.