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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

A Study of DC6001 Tablet in Healthy Chinese Adult Subjects

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

A Study of DC6001 Tablet in Healthy Chinese Adult Subjects (NCT07417566) is a Phase 1 interventional studying Stargardt Disease, sponsored by Heronova Pharmaceuticals. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Stargardt Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 76 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Stargardt Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Healthy volunteers aged 18-55 years (inclusive) at the time of signing the willing to sign a consent form 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

DC6001

DC6001 tablet

DRUG

Placebo

DC6001 placebo tablet

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Tongren Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07417566), the sponsor (Heronova Pharmaceuticals), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07417566 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07417566?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07417566?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07417566. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07417566. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.