A Food-Effect Study of CX11 in Healthy Participants

NCT07349381 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CX11101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes; Obesity & Overweight

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-time curve from 0 to 24 hour (AUC0-24) of CX11 (VCT220)

  AUC0-24 of of CX11 (VCT220)

  Predose at Day1 up to 35 days postdose

• Maximum Observed Concentration (Cmax) of CX11 (VCT220)

  Cmax of CX11 (VCT220)

  Predose at Day1 up to 35 days postdose

• Time to Maximum Observed Concentration (Tmax) of CX11 (VCT220)

  Tmax of CX11 (VCT220)

  Predose at Day 1 up to 35 days postdose

Study Arms (2)

Fasted-Fed Arm

EXPERIMENTAL

Fasted-Fed Group

Drug: CX11 (VCT220)

Fed-Fasted Arm

EXPERIMENTAL

Fed-Fasted Group

Drug: CX11 (VCT220)

Interventions

CX11 (VCT220) 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

Fasted-Fed Arm; Fed-Fasted Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vincentage Pharma Co., Ltd: lead
• Corxel Pharmaceuticals: collaborator

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Wang

CONTACT

+86-13918150895; Yinghua.wang@corxelbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)