Actively Recruiting
A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
Led by Heronova Pharmaceuticals · Updated on 2026-02-18
76
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of DC6001 Tablet in Healthy Chinese Adult Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers aged 18-55 years inclusive at the time of consent
- Males weighing at least 50.0 kg; females weighing at least 45.0 kg
- Body mass index (BMI) between 19.0 and 28.0 kg/m² inclusive
- Women of childbearing potential and male subjects agree to use effective contraception for 6 months from pre-screening to last drug administration
- Negative serum pregnancy test for women of childbearing potential before first drug dose
- No history of major diseases; normal or clinically insignificant physical exam, vital signs, ECG, chest X-ray, and lab results
- Ability to communicate well with investigators, comply with trial requirements, and provide informed consent
You will not qualify if you...
- Clinically significant abnormalities or diseases within 1 week before screening or currently present requiring exclusion
- Digestive system diseases affecting fat-soluble vitamin absorption within 3 months before screening or currently present
- Diseases related to vitamin A deficiency within 3 months before screening or currently present
- Acute diseases from screening to first drug dose that may affect study results
- History of severe visual, ocular, or retinal diseases
- Dysphagia
- Known or suspected allergies to the study drug or its ingredients
- Clinically significant atopy or allergic disease history
- Surgery within 3 months before screening or planned surgery during the study
- Blood donation or loss of ≥400 mL, or blood transfusion within 3 months before first drug dose or planned donation during study
- Participation in other investigational drug studies within 3 months before first drug dose
- Smoking more than 5 cigarettes daily within 3 months before first drug dose or inability to abstain during study
- Consuming more than 14 alcohol units weekly within 3 months before first drug dose or inability to abstain during study
- Excessive intake of tea, coffee, or caffeinated drinks within 3 months before first drug dose or inability to abstain during study
- Use of prescription, over-the-counter, or herbal medicines, vitamins, or health foods within 28 days before screening or within 5 drug half-lives
- ECG abnormalities during screening including PR interval >200 ms, QTcF >450 ms, QRS duration >110 ms, QT interval >500 ms, or heart rate <50 bpm
- Pregnant or lactating women, or positive pregnancy test prior to first drug dose
- Positive infectious or immunological tests deemed significant
- Positive urine drug screen or history of drug abuse within 5 years
- Consumption of certain fruits, caffeine, alcohol, or special diets affecting drug metabolism within 72 hours before first drug dose
- Special dietary needs, lactose intolerance, or inability to accept unified diet
- Investigator judgment deeming subject unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
K
Kang Ren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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