A Study of DC6001 Tablet in Healthy Chinese Adult Subjects (NCT07417566) | Clinical Trial Compass
RecruitingPhase 1
A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
China76 participantsStarted 2026-01-01
Plain-language summary
This study adopts a randomized, double-blind, parallel placebo-controlled dose-escalation design, consisting of two parts: Part 1 includes a single ascending dose (SAD) study plus a food effect (FE) study, and Part 2 is a multiple ascending dose (MAD) study.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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 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 dysphagia;
✕. 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 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;