D-0120 Safety and PK/PD Study in China (NCT03923868) | Clinical Trial Compass
CompletedPhase 1/2
D-0120 Safety and PK/PD Study in China
China52 participantsStarted 2019-04-18
Plain-language summary
It is a randomized, double-blind, placebo-controlled, multiple-administration, multiple-dose, dose-escalating, phase Ib/IIa clinical study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy subjects and hyperuricemia patients (gout or asymptomatic) in China.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years old and ≤ 65 years old;
. Phase Ib: fasting sUA in the morning of screening period (fasted after 8:00 pm on the previous day) of healthy subjects meets the following requirement: 270 umol/l (4.5 mg/dL) ≤ sUA \<420 umol/l (7 mg/dL)
. Subject's BMI range is 18.0\~32.0 kg/m2 (inclusive);
. Female subjects must be non-pregnant and non-lactating, surgically sterilized or ≥ 60 years old. Male subjects must be surgically sterilized or agree to practice sexual abstinence;
. Results of routine blood tests, blood biochemical tests and routine urine tests are within the normal range or clinically insignificant as judged by the principle investigator. Routine urine tests include normal urine creatinine, urine protein/creatinine ratio. ECGs are within the normal range or clinically insignificant as judged by the principle investigator.
. Subjects have the ability to follow study and follow-up procedures.
. Subjects have the ability to understand the study protocol and the risks involved, and must provide signed informed consent form to participate in the study.
Exclusion criteria
. History of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, nervous, hepatic, renal, urinary, gastrointestinal, immune, endocrine, psychiatric diseases, or clinical abnormalities that may pose excessive risks to the subjects or affect outcome or study interpretation at the discretion of the investigators;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number of subjects with treatment-related adverse events as assessed
. Allergic constitution, or allergy to any drug used in the study or any ingredient of study drug;
. History of malignant tumors;
. Subjects with positive results of any of the following items: screening hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg) and treponema pallidum (only for phase Ib healthy subjects);
. Urinary calculi confirmed by B-ultrasound during screening period;
. Myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack within 3 months prior to screening;
. Participation in clinical studies of any investigational drugs or medical devices within 3 months prior to screening;
. Major surgery within 3 months prior to randomization;