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โ† Trials
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A Study of DC6001 Tablet in Healthy Chinese Adult Subjects

RecruitingPhase 1Ages 18 Years - 55 YearsAllHeronova Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender; 2. Male subjects with a body weight โ‰ฅ 50.0 kg and female subjects with a body weight โ‰ฅ 45.0 kg; BMI ranging from 19.0 to 28.0 kg/mยฒ (inclusive of critical values); 3. 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; 4. 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; 5. 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: 1. Subjects with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion; 2. Subjects with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently present; 3. Subjects with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present; 4. 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; 5. History of severe visual, ocular, or retinal diseases; 6. Subjects with dysphagia; 7. 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); 8. 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; 9. Subjects who have donated blood, lost a large amount of blood (โ‰ฅ 400 mL), donated โ‰ฅ 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; 10. 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; 11. 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; 12. 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; 13. 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; 14. 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); 15. 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; 16. 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; 17. 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; 18. Subjects with a positive urine drug screen or a history of drug abuse or drug use within 5 years prior to the study; 19. 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; 20. Subjects with special dietary requirements, lactose intolerance, or inability to accept a unified diet; 21. Subjects deemed unsuitable for participation in the study by the investigator.
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What it tests

  • DC6001
  • Placebo
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Where

1 site
Beijing Tongren Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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