A Food-Effect Study of CX11 in Healthy Participants

Vincentage Pharma Co., Ltd

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Obesity & Overweight; Type 2 Diabetes

Treatments: Drug: CX11 (VCT220)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07349381

CX11101

Details and patient eligibility

About

This study is to evaluate the food effect (FE) on the PK of 200 mg CX11 in healthy participants

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Fasted-Fed Arm

Experimental group

Description:

Fasted-Fed Group

Treatment:

Drug: CX11 (VCT220)

Fed-Fasted Arm

Experimental group

Description:

Fed-Fasted Group

Treatment:

Drug: CX11 (VCT220)