Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase I Trial to Evaluate Safety and Pharmacokinetics of Oral DC6001 Tablet in Healthy Chinese Adults
Led by Heronova Pharmaceuticals · Updated on 2026-02-18
76
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, double-blind, placebo-controlled Phase I trial to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral DC6001 tablets in healthy Chinese adults aged 18 to 55 years. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) parts to evaluate how the drug behaves in the body and its potential effects. The trial aims to gather detailed information on adverse events and drug concentration over time to support further development. The trial is divided into two main parts. Part 1 includes five dose groups (2 mg, 5 mg, 10 mg, 20 mg, and 40 mg) where participants receive a single dose of DC6001 or placebo under fasting and fed conditions. The 5 mg group also undergoes a food effect study to see how a high-fat meal affects drug absorption. Part 2 involves three dose groups (2 mg, 5 mg, and 10 mg) where participants take DC6001 or placebo once daily for 14 days. Dose escalation proceeds sequentially, with safety reviews before moving to higher doses. Participants will undergo blood sample collections, safety assessments, physical examinations, ECGs, and laboratory tests throughout the study. Researchers will monitor adverse events for up to 28 days and measure drug levels in plasma over several hours to days after dosing. The study includes discharge safety exams after each treatment cycle and careful follow-up to evaluate tolerability and pharmacokinetic parameters. Total participation time varies depending on the study part and dosing schedule.
CONDITIONS
Brief 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 to 55 years at consent
- Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg
- BMI between 19.0 and 28.0 kg/m inclusive
- Women of childbearing potential or male subjects must agree to use effective contraception for 6 months and have no plans for sperm or egg donation
- Negative pregnancy test for women of childbearing potential before first dose
- No history of major diseases
- Normal or clinically insignificant physical exam, vital signs, ECG, chest X-ray, and lab tests
- Ability to communicate well, comply with study requirements, and sign informed consent
You will not qualify if you...
- Clinically significant abnormalities or diseases within 1 week prior to screening or currently present
- Digestive system diseases affecting fat-soluble vitamin absorption within 3 months prior to screening or currently present
- Diseases related to vitamin A deficiency within 3 months prior to screening or currently present
- Acute diseases from screening to first drug administration that may affect results
- History of severe visual, ocular, or retinal diseases
- Dysphagia
- Known or suspected allergic reactions to study drug or excipients
- Clinically significant atopy or history of allergic diseases
- Surgery within 3 months prior to screening that may affect drug processing or planned surgery during study
- Blood donation or transfusion within 3 months prior to first drug administration or planned donation during study
- Participation in other investigational drug studies within 3 months prior to first drug administration
- Smoking more than 5 cigarettes daily within 3 months prior or inability to abstain during study
- Consuming more than 14 units of alcohol weekly within 3 months prior or inability to abstain during study
- Excessive caffeine intake within 3 months prior or inability to abstain during study
- Use of prescription, over-the-counter, herbal medicines, vitamins, or health foods within 28 days prior to screening or within 5 drug half-lives
- ECG abnormalities including prolonged PR, QTcF, QRS, QT intervals, or low heart rate
- Pregnant or lactating women, or positive pregnancy test
- Positive infectious or immunological tests deemed clinically significant
- Positive drug screen or history of drug abuse within 5 years
- Consumption of certain fruits, caffeine, alcohol, or special diets within 72 hours prior to first dose
- Special dietary requirements, lactose intolerance, or inability to accept unified diet
- Any condition deemed unsuitable by investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 days
Participants receive a single oral dose of DC6001 or placebo under fasting and fed conditions with blood sample collections and safety assessments.
Visits on Day 1, Day 9, and Day 10 (in-person)
Duration - 14 days
Participants receive DC6001 or placebo orally once daily under fasting conditions for 14 consecutive days with safety assessments.
Daily visits or assessments during dosing period
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
K
Kang Ren
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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