A Study of DC6001 Tablet in Healthy Chinese Adult Subjects

NCT07417566 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SHRC-CRDC06-01-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stargardt Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  Incidence and severity of adverse events as assessed by CTCAE Version 6.0

  Up to 28 days

Secondary Outcomes (6)

• The maximum plasma concentration of the drug (Cmax)

  From time zero up to 192 hours post-dose

• The time at which the peak plasma concentration is reached (Tmax)

  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)

  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: From time zero up to 192 hours post-dose

• The time required for the plasma concentration to decrease by half (T1/2)

  From time zero up to 192 hours post-dose

Study Arms (5)

SAD: DC6001

EXPERIMENTAL

Participants received single dose of DC6001 orally. Dose levels are 2 mg, 5 mg, 10 mg, 20 mg and 40 mg.

Drug: DC6001

SAD: Placebo

PLACEBO COMPARATOR

Participants received single dose of placebo orally.

Drug: Placebo

MAD: DC6001

EXPERIMENTAL

Participant received DC6001 orally once daily for 14 days. Dose levels are 2 mg, 5 mg and 10 mg.

Drug: DC6001

MAD: Placebo

PLACEBO COMPARATOR

Participant received DC6001 placebo matching DC6001 orally once daily for 14 days.

Drug: Placebo

FE: DC6001

EXPERIMENTAL

Participants received single dose of DC6001 5 mg orally under fed conditions.

Drug: DC6001

Interventions

DC6001 DRUG

DC6001 tablet

FE: DC6001; MAD: DC6001; SAD: DC6001

Placebo DRUG

DC6001 placebo tablet

MAD: Placebo; SAD: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Heronova Pharmaceuticals: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Stargardt Disease

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Kang Ren

CONTACT

+86-13269683867; renkang@dcpc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)