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New treatment option for Stargardt Disease
Official title A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
ClinicalTrials.gov ID: NCT07417566
What this study is testing
What is DC6001?
DC6001 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for stargardt disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender;
- Male people with a body weight ≥ 50.0 kg and female people with a body weight ≥ 45.0 kg; BMI ranging from 19.0 to 28.0 kg/m² (inclusive of critical...
- Women of childbearing potential (WOCBP) or male people must agree to have no childbearing plans and voluntarily adopt effective contraceptive...
- No history of major diseases; physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray, and laboratory test results during...
- people are able to maintain good communication with the investigator, comply with all requirements of the clinical trial, and voluntarily sign the...
You likely can't join if
- people with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion;
- people with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently...
- people with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present;
- people with acute diseases occurring from the screening phase to the first administration of the study drug that, in the investigator's judgment, may...
- History of severe visual, ocular, or retinal diseases;
- people with dysphagia;
See the full eligibility criteria
Who can join
- Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender;
- Male people with a body weight ≥ 50.0 kg and female people 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 people 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...
- 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...
- people are able to maintain good communication with the investigator, comply with all requirements of the clinical trial, and voluntarily sign the informed consent form.
What rules you out
- people with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion;
- people with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently present;
- people with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present;
- people 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;
- people with dysphagia;
- people with known or suspected allergic reactions to the study drug or any of its excipients (as judged by the investigator); or people with clinically significant atopy or history of allergic diseases (as judged by the...
- people 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 people...
- people 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 people...
- people who have received any investigational drug or participated in any treatment clinical study within 3 months prior to the first administration of the study drug;
- people 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;
- people 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...
- people 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...
- people 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...
- people 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...
- Pregnant or lactating female people; or female people of childbearing potential (WOCBP) with a positive serum pregnancy test at any time prior to the first administration;
- people 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...
- people with a positive urine drug screen or a history of drug abuse or drug use within 5 years prior to the study;
- people 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...
- people with special dietary requirements, lactose intolerance, or inability to accept a unified diet;
- people deemed unsuitable for participation in the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.