A Food-Effect Study of CX11 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-26

Study Completion Date

2026-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Obesity & Overweight Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fasted-Fed Arm

Fasted-Fed Group

Group Type EXPERIMENTAL

CX11 (VCT220)

Intervention Type DRUG

CX11 (VCT220) administered orally to participants who are in fasted/fed state in the first 6 consecutive days, and in fed/fasted state on the 7th day

Fed-Fasted Arm

Fed-Fasted Group

Group Type EXPERIMENTAL

CX11 (VCT220)

Intervention Type DRUG

CX11 (VCT220) administered orally to participants who are in fasted/fed state in the first 6 consecutive days, and in fed/fasted state on the 7th day

Interventions

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CX11 (VCT220)

CX11 (VCT220) administered orally to participants who are in fasted/fed state in the first 6 consecutive days, and in fed/fasted state on the 7th day

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes