DC6001 tablets in healthy Chinese adults

A Randomized, Double-Blind, Parallel Placebo-Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Oral DC6001 Tablet in Healthy Chinese Adult Subjects

This trial will test single and repeated doses of DC6001 tablets in healthy Chinese adults to see how the drug is tolerated, how the body handles it, and whether food affects absorption.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Heronova Pharmaceuticals (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07417566 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, parallel, placebo-controlled Phase 1 trial uses a dose-escalation approach with single ascending dose (SAD) and food-effect (FE) components followed by a multiple ascending dose (MAD) component. Part 1 enrolls about 46 healthy adults across five SAD dose groups (2, 5, 10, 20, 40 mg) with a dedicated FE assessment using fasting and high-fat conditions. Part 2 plans about 30 healthy adults in up to three MAD groups (tentatively 2, 5, 10 mg) dosed once daily for 14 days, with randomization to DC6001 or placebo in each cohort. Safety, tolerability, and pharmacokinetics will guide dose escalation and decisions to proceed between parts.

Who should consider this trial

Good fit: Healthy adults aged 18–55 years with body weight ≥50 kg for males or ≥45 kg for females, BMI 19.0–28.0 kg/m², no major medical history, normal or clinically insignificant screening tests, and willingness to use effective contraception are ideal candidates.

Not a fit: People with significant medical conditions, abnormal screening labs or ECG, pregnant or breastfeeding individuals, those outside the specified age/weight/BMI ranges, or anyone unwilling to follow contraceptive requirements will not be eligible and are unlikely to benefit from participation.

Why it matters

Potential benefit: If DC6001 is safe and shows favorable pharmacokinetics, it could move into patient trials and potentially become a new oral treatment option for people with Stargardt disease.

How similar studies have performed: Dose-escalation SAD/MAD and food-effect designs are common and have supported development of many drugs, but DC6001 itself appears to be untested in humans to date.

Eligibility criteria

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 ≥ 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);
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 (≥ 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;
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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tongren Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Kang Ren

Conditions Stargardt Disease