Food Effect and Multiple-Dose Study of Chiglitazar/Metformin Extended-Release Tablets

A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar/Metformin Extended-Release Fixed Dose Combination Tablets

This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.

The FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants.

The multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar/Metformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.

Study Overview

• Status: Not yet recruiting
• Conditions: T2DM (Type 2 Diabetes Mellitus)
• Intervention / Treatment: Drug: Chiglitazar/Metformin extended-release tablets under fasting conditions; Drug: Chiglitazar/Metformin extended-release tablets after a high-fat meal; Drug: multiple-dose of Chiglitazar/Metformin extended-release tablets

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female participants；
• Age from 18 to 45 years, inclusive；
• Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；
• From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；
• Voluntarily agrees to participate in the study and signs the informed consent form.

Exclusion Criteria:

• Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine/metabolic disorders;
• Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;
• Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;
• Surgery within 3 months prior to screening or planned surgery during the study period;
• Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;
• History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;
• Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;
• Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;
• History of drug or substance abuse, or a positive alcohol or urine drug screening test;
• Intolerance to venipuncture, or a history of fainting in response to needles or blood;
• Fasting blood glucose > 6.1 mmol/L or < 3.9 mmol/L at screening, and/or a history of hypoglycemia/syncope;
• Participation in any interventional clinical trial within 3 months prior to screening;
• Blood donation or significant blood loss (> 200 mL) within 3 months prior to screening;
• Pregnant or lactating women;
• Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;
• Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;
• Excessive daily consumption of tea, coffee, and/or caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;
• Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;
• Glomerular Filtration Rate (GFR) < 90 mL/min/1.73 m²;
• Systolic blood pressure < 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure < 50 mmHg or ≥ 90 mmHg at screening;
• Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;
• Plans to or is required to engage in strenuous physical activity or exercise during the study period;
• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1 of FE study	Drug: Chiglitazar/Metformin extended-release tablets under fasting conditions; a single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions; Drug: Chiglitazar/Metformin extended-release tablets after a high-fat meal; a single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal
Experimental: Sequence 2 of FE study	Drug: Chiglitazar/Metformin extended-release tablets under fasting conditions; a single dose of Chiglitazar/Metformin extended-release tablets under fasting conditions; Drug: Chiglitazar/Metformin extended-release tablets after a high-fat meal; a single dose of Chiglitazar/Metformin extended-release tablets after a high-fat meal
Experimental: multiple-dose group	Drug: multiple-dose of Chiglitazar/Metformin extended-release tablets; a single dose on Day 1, once-daily consecutive doses from Day 4 to Day 10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FE Study: Maximum plasma concentration (Cmax)	Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Area Under the Plasma Concentration-Time Curve (AUC)	Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Time to Maximum Plasma Concentration（Tmax）	Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Elimination Half-life （t1/2）	Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Apparent Total Clearance （CL/F）	Pre-dose and at multiple timepoints post-dose up to 72 hours
FE Study: Apparent Volume of Distribution during the terminal phase （Vz/F）	Pre-dose and at multiple timepoints post-dose up to 72 hours
Multiple-dose PK study: Maximum plasma concentration (Cmax)	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: Area Under the Plasma Concentration-Time Curve (AUC)	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: Time to Maximum Plasma Concentration（Tmax）	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: steady-state peak concentration (Cmax,ss)	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: steady-state time to peak concentration (Tmax,ss)	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: under the plasma concentration-time curve at steady state (AUCss)	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: trough concentration (Ctrough)	predose to 72 hours after the last dose (7 consecutive days of dosing)
Multiple-dose PK Study: accumulation ratio (Rac)	predose to 72 hours after the last dose (7 consecutive days of dosing)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (AEs)		up to Day 16
Change from baseline in hematology parameters: white blood cell count, neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count , hemoglobin, hematocrit, platelet count	Change from baseline in hematology parameters: white blood cell count (WBC), neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count, red blood cell count (RBC), hemoglobin (Hb), hematocrit (HCT), platelet count (PLT)	up to Day 13
Changes from baseline in serum chemistry parameters	Changes from baseline in serum chemistry parameters: fasting blood glucose (FBG), total protein, albumin, total bilirubin, direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), blood urea nitrogen (BUN) or urea, uric acid, creatinine, potassium (K⁺), sodium (Na⁺), chloride (Cl-), creatine kinase (CK)	up to Day 13
Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells	Changes from baseline in urinalysis parameters: urine protein, urine ketones, urine glucose, urine pH, urine leukocytes, urine red blood cells (RBCs)	up to Day 13

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): October 26, 2026

Study Registration Dates

• First Submitted: March 20, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; chiglitazar
• Other Study ID Numbers: CGZ111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No