A Food-Effect Study of CX11 in Healthy Participants (NCT07349381) | Clinical Trial Compass
RecruitingPhase 1
A Food-Effect Study of CX11 in Healthy Participants
China32 participantsStarted 2026-03-04
Plain-language summary
This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants
Who can participate
Age range
18 Years – 45 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
. Fully understand the objective, nature, methods, and possible adverse reactions of the study; be able to communicate well with the investigator; voluntarily take part in the study and be willing to comply with the requirements of this study; and sign the informed consent form before all study procedures are started
. Weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) is ≥ 20.0 kg/m2 and \< 28 kg/m2 at the screening visit and on Day 21.
Exclusion criteria
. Participants with allergic constitution or known previous history of allergy to CX11 or similar compounds and related excipients, or history of atopic allergic diseases
. Participants who have experienced clinically significant acute diseases during the pre-study screening period or within 2 weeks prior to the first dose of the investigational product
. Participants who have pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function that could affect drug absorption, distribution, metabolism, and/or excretion as judged by the investigator, or plan to receive any surgery during the study
. Participants suffering from any clinically significant chronic diseases, including but not limited to disorders of the respiratory system, cardiovascular system, urinary system, blood system, endocrine system, and immune system, as well as the digestive system (e.g., history of or current fatty liver disease, including metabolic dysfunction-associated steatohepatitis
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.
What they're measuring
1
Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)
Timeframe: Predose at Day1 up to 35 days postdose
2
Maximum Observed Concentration (Cmax) of CX11 (VCT220)
Timeframe: Predose at Day1 up to 35 days postdose
3
Time to Maximum Observed Concentration (Tmax) of CX11 (VCT220)
Timeframe: Predose at Day 1 up to 35 days postdose
. History of thyroid dysfunction requiring medication or with a thyroid stimulating hormone (TSH) level exceeding the normal reference range at screening or on Day 21
. Participants who have been vaccinated within 30 days before the screening or plan to be vaccinated during the study
. Participated in any other clinical study and received an investigational intervention within 90 days or 5 elimination half-lives (whichever is longer) of the investigational intervention, prior to screening