Stargardt DiseasePhase 1NCT07417566
A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
A Phase 1 study testing DC6001 in people with Stargardt Disease, run by Heronova Pharmaceuticals at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stargardt Disease
- What is being tested?
- DC6001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- 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 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;
- 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;
- 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;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Laichun Lu, +8613883933701, lulaicq@163.com
About this study
Official title: 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 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.
Read the detailed description
Part 1: SAD and FE Studies The SAD and FE studies are conducted concurrently, with a total of 5 dose groups: 2 mg, 5 mg, 10 mg, 20 mg, and 40 mg. A total of 46 healthy adult subjects are planned for enrollment. Except for the 5 mg group, each dose group will include 8 subjects, who will be randomly assigned to receive DC6001 tablets (6 subjects) or DC6001 placebo (2 subjects). The 5 mg group will be combined with the FE study, with 14 planned subjects randomly allocated to DC6001 tablets (12 subjects) or placebo (2 subjects). In the first cycle, a single dose will be administered under fasting conditions. After blood sample collection and safety assessment on Day 9 (D9), the second cycle will be conducted on Day 10 (D10) with administration under high-fat postprandial conditions, followed by blood sample collection and discharge safety examinations.
Part 2: MAD Study The MAD study is tentatively designed with 3 dose groups: 2 mg, 5 mg, and 10 mg (to be adjusted based on SAD study results). A total of 30 healthy adult subjects are planned for enrollment, with 10 subjects per dose group randomly assigned to receive DC6001 tablets (8 subjects) or DC6001 placebo (2 subjects). The tentative administration regimen is once-daily fasting administration for 14 consecutive days (to be adjusted based on SAD study results).
The SAD and MAD study will proceed sequentially from the lowest dose group. After subjects in a given dose group complete discharge safety examinations, the Safety Review Committee (SRC) will assess whether the dose escalation termination criteria are met. If not, the dose will be escalated to the next group until the highest dose group is completed.
- Conditions
- Stargardt Disease
- Being tested
- DC6001, Placebo
- Medical subject headings
- Stargardt Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC6001Drug
DC6001 tablet
PlaceboDrug
DC6001 placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| SAD: DC6001 | Experimental | Participants received single dose of DC6001 orally. Dose levels are 2 mg, 5 mg, 10 mg, 20 mg and 40 mg. Receives: Drug: DC6001 |
| SAD: Placebo | Placebo comparator | Participants received single dose of placebo orally. Receives: Drug: Placebo |
| MAD: DC6001 | Experimental | Participant received DC6001 orally once daily for 14 days. Dose levels are 2 mg, 5 mg and 10 mg. Receives: Drug: DC6001 |
| MAD: Placebo | Placebo comparator | Participant received DC6001 placebo matching DC6001 orally once daily for 14 days. Receives: Drug: Placebo |
| FE: DC6001 | Experimental | Participants received single dose of DC6001 5 mg orally under fed conditions. Receives: Drug: DC6001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Incidence and severity of adverse events as assessed by CTCAE Version 6.0
Measured: Up to 28 days
Secondary outcomes (6)
The maximum plasma concentration of the drug (Cmax)
Measured: From time zero up to 192 hours post-dose
The time at which the peak plasma concentration is reached (Tmax)
Measured: From time zero up to 192 hours post-dose
The area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Measured: From time zero up to 192 hours post-dose
The area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Measured: Time Frame: From time zero up to 192 hours post-dose
The time required for the plasma concentration to decrease by half (T1/2)
Measured: From time zero up to 192 hours post-dose
Change from baseline in plasma RBP4 levels
Measured: From time zero up to 336 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stargardt DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heronova Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417566
- Sponsor's protocol ID
- SHRC-CRDC06-01-01
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07417566
- Acronym / sponsor ID
- SHRC-CRDC06-01-01
- Conditions
- Stargardt Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Heronova PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part 1: SAD and FE Studies The SAD and FE studies are conducted concurrently, with a total of 5 dose groups: 2 mg, 5 mg, 10 mg, 20 mg, and 40 mg. A total of 46 healthy adult subjects are planned for enrollment. Except for the 5 mg group, each dose group will include 8 subjects, who will be randomly assigned to receive DC6001 tablets (6 subjects) or DC6001 placebo (2 subjects). The 5 mg group will be combined with the FE study, with 14 planned subjects randomly allocated to DC6001 tablets (12 subjects) or placebo (2 subjects). In the first cycle, a single dose will be administered under fasting conditions. After blood sample collection and safety assessment on Day 9 (D9), the second cycle will be conducted on Day 10 (D10) with administration under high-fat postprandial conditions, followed by blood sample collection and discharge safety examinations.
Part 2: MAD Study The MAD study is tentatively designed with 3 dose groups: 2 mg, 5 mg, and 10 mg (to be adjusted based on SAD study results). A total of 30 healthy adult subjects are planned for enrollment, with 10 subjects per dose group randomly assigned to receive DC6001 tablets (8 subjects) or DC6001 placebo (2 subjects). The tentative administration regimen is once-daily fasting administration for 14 consecutive days (to be adjusted based on SAD study results).
The SAD and MAD study will proceed sequentially from the lowest dose group. After subjects in a given dose group complete discharge safety examinations, the Safety Review Committee (SRC) will assess whether the dose escalation termination criteria are met. If not, the dose will be escalated to the next group until the highest dose group is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SAD: DC6001 | Experimental | Drug: DC6001Participants received single dose of DC6001 orally. Dose levels are 2 mg, 5 mg, 10 mg, 20 mg and 40 mg. |
| SAD: Placebo | Placebo comparator | Drug: PlaceboParticipants received single dose of placebo orally. |
| MAD: DC6001 | Experimental | Drug: DC6001Participant received DC6001 orally once daily for 14 days. Dose levels are 2 mg, 5 mg and 10 mg. |
| MAD: Placebo | Placebo comparator | Drug: PlaceboParticipant received DC6001 placebo matching DC6001 orally once daily for 14 days. |
| FE: DC6001 | Experimental | Drug: DC6001Participants received single dose of DC6001 5 mg orally under fed conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC6001DC6001 tablet | Drug | FE: DC6001, MAD: DC6001, SAD: DC6001 |
| PlaceboDC6001 placebo tablet | Drug | MAD: Placebo, SAD: Placebo |
Primary outcome
Number of Participants With Adverse Events
Time frame: Up to 28 days
Incidence and severity of adverse events as assessed by CTCAE Version 6.0
6 secondary outcomes
The maximum plasma concentration of the drug (Cmax)
Time frame: From time zero up to 192 hours post-dose
The time at which the peak plasma concentration is reached (Tmax)
Time frame: From time zero up to 192 hours post-dose
The area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC0-t)
Time frame: From time zero up to 192 hours post-dose
The area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: Time Frame: From time zero up to 192 hours post-dose
The time required for the plasma concentration to decrease by half (T1/2)
Time frame: From time zero up to 192 hours post-dose
Change from baseline in plasma RBP4 levels
Time frame: From time zero up to 336 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC6001 in people with Stargardt Disease, run by Heronova Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang Ren (+86-13269683867, renkang@dcpc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.