A Study of DC6001 Tablet in Healthy Chinese Adult Subjects

Korábbi kezelés

• Subjects with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion;
• Subjects with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently present;
• Subjects with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present;
• Subjects who have undergone surgery within 3 months prior to screening that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion, or have severe surgical sequelae; or subjects planning to undergo surgery during the study;
• Subjects who have donated blood, lost a large amount of blood (≥ 400 mL), donated ≥ 2 units of component blood, or received blood transfusion within 3 months prior to the first administration of the study drug; or subjects planning to donate blood during the study;
• Subjects who have received any investigational drug or participated in any interventional clinical study within 3 months prior to the first administration of the study drug;
• Subjects who smoked an average of more than 5 cigarettes per day within 3 months prior to the first administration of the study drug, or cannot abstain from using any tobacco products during the study;
• Subjects who consumed an average of more than 14 units of alcohol per week within 3 months prior to the first administration of the study drug, or cannot abstain from using any alcohol-containing products during the study; or subjects with a positive breath alcohol test prior to study drug administration;
• Subjects who consumed excessive tea, coffee, and/or caffeinated beverages within 3 months prior to the first administration of the study drug, or cannot abstain from consuming tea, coffee, and/or caffeinated beverages during the study;
• Subjects who used any prescription drugs, over-the-counter drugs, Chinese patent medicines, Chinese herbal medicines, vitamins, or health food products within 28 days prior to screening or within 5 drug half-lives (whichever is shorter);
• Subjects with a positive urine drug screen or a history of drug abuse or drug use within 5 years prior to the study;
• Subjects who consumed or drank pitaya, mango, grapefruit, carambola, or foods/beverages prepared from these fruits; or foods/beverages containing xanthine, caffeine, or alcohol; or other special diets that may affect drug absorption, distribution, metabolism, or excretion within 72 hours prior to the first administration;

Más betegség

• Subjects with acute diseases occurring from the screening phase to the first administration of the study drug that, in the investigator's judgment, may affect the study results;
• History of severe visual, ocular, or retinal diseases;
• Subjects with known or suspected allergic reactions to the study drug or any of its excipients (as judged by the investigator); or subjects with clinically significant atopy or history of allergic diseases (as judged by the investigator);
• Subjects with positive results or results exceeding the upper limit of the reference range in the eight infectious and immunological tests, which are deemed clinically significant by the investigator: hepatitis B virus (HBV) serology, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV)-P24 antigen/antibody, and syphilis-specific antibody;

Laborértékek

• Subjects whose 12-lead electrocardiogram (ECG) during the screening period meets any of the following criteria: 1) PR interval > 200 ms; 2) QTcF > 450 ms; 3) QRS duration > 110 ms; 4) QT interval > 500 ms; 5) Heart rate (HR) < 50 bpm;
• Pregnant or lactating female subjects; or female subjects of childbearing potential (WOCBP) with a positive serum pregnancy test at any time prior to the first administration;

Egyéb

• Subjects with dysphagia;
• Subjects with special dietary requirements, lactose intolerance, or inability to accept a unified diet;
• Subjects deemed unsuitable for participation in the study by the investigator.

• Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender;
• Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg; BMI ranging from 19.0 to 28.0 kg/m² (inclusive of critical values);
• Women of childbearing potential (WOCBP) or male subjects must agree to have no childbearing plans and voluntarily adopt effective contraceptive measures for 6 months from pre-screening to the last administration of the study drug, with no plans for sperm or egg donation. For WOCBP: The serum pregnancy test result of WOCBP must be negative before the first administration;
• No history of major diseases; physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray, and laboratory test results during screening are normal, or slightly exceed the normal reference range but are deemed clinically insignificant by the investigator;
• Subjects are able to maintain good communication with the investigator, comply with all requirements of the clinical trial, and voluntarily sign the informed consent form.