How eating affects CX11 (200 mg) in healthy adults
An Open-label, Randomized, Multiple-dose, Two-cycle, Two-way Crossover Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of CX11 Tablets in Healthy Participants
This test sees if eating a meal changes how a single 200 mg dose of CX11 is absorbed and processed in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Vincentage Pharma Co., Ltd Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07349381 on ClinicalTrials.gov |
What this trial studies
This Phase 1 pharmacokinetic study compares how a 200 mg oral dose of CX11 is handled by the body when taken with food versus when taken fasting. Participants will receive CX11 under controlled fed and fasting conditions and have timed blood samples taken to measure drug levels and standard safety labs. Eligible volunteers meet specified weight and BMI criteria and must not have relevant allergies, recent acute illnesses, or significant gastrointestinal, hepatic, or renal disorders. The study is conducted at Shanghai Xuhui Central Hospital with close medical monitoring for adverse reactions.
Who should consider this trial
Good fit: Healthy adults who can give informed consent, meet the weight and BMI criteria (men ≥50 kg, women ≥45 kg, BMI 20.0–<28 kg/m2), and can comply with study procedures are ideal candidates.
Not a fit: People with a history of allergy to CX11 or similar compounds, recent clinically significant acute illness, or pre-existing gastrointestinal, hepatic, or renal conditions are unlikely to benefit and are excluded.
Why it matters
Potential benefit: If successful, the results could guide dosing instructions around meals and improve the safety and effectiveness of CX11 in future trials for overweight, obesity, or type 2 diabetes.
How similar studies have performed: Food-effect pharmacokinetic studies are a routine part of drug development and are commonly successful at defining how meals change drug absorption.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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 2. 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: 1. Participants with allergic constitution or known previous history of allergy to CX11 or similar compounds and related excipients, or history of atopic allergic diseases 2. 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 3. 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 4. 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 5. 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 6. Participants who have been vaccinated within 30 days before the screening or plan to be vaccinated during the study 7. 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
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai Xuhui Central Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wang
- Email: Yinghua.wang@corxelbio.com
- Phone: +86-13918150895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.