A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
ConditionStargardt Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHeronova Pharmaceuticals
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- DC6001
- Placebo
Treatment groups
76 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov