- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03923868
D-0120 Safety and PK/PD Study in China
May 5, 2022 updated by: InventisBio Co., Ltd
A Randomized, Double-blind, Placebo-controlled, Multiple-administration, Multiple-dose, Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of D-0120 Tablets in Healthy Subjects and Hyperuricemia Patients in China
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
-
Bengbu, Anhui, China
- Site 04
-
-
Jiangsu
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Nanjing, Jiangsu, China
- Site 03
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Nanjing, Jiangsu, China
- Site 07
-
-
Zhejiang
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Hangzhou, Zhejiang, China
- Site 01- The second affiliated hospital of zhejiang university school of medicine
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Huzhou, Zhejiang, China
- Site 06
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Wenzhou, Zhejiang, China
- Site 05
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Phase IIa: hyperuricemia subjects should meet any of the following:
- 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;
- 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;
- Any clinically significant acute diseases within one month prior to screening at the discretion of the investigators;
- Gout flare within 14 days prior to randomization;
- Use of other uric acid-lowering drugs (allopurinol, febuxostat, probenecid, benzbromarone) within 14 days prior to randomization;
- Daily dose of aspirin > 100 mg within 14 days before randomization;
- Use of any diuretic within 14 days before randomization;
- Use of any Chinese herbal medicine within 14 days before randomization;
- History of drug abuse or alcohol abuse (for phase Ib healthy subjects, the screening alcohol test and urine drug test are positive);
- Any situation that may prevent the subject from completing the study or pose a significant risk to the subject as considered by any investigator;
- Any other situation that may pose excessive risks to the subject or affect outcome or study interpretation as considered by any investigator;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dose escalation in healthy subjects
|
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
|
Experimental: dose escalation in hyperuricemia patients
|
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The number of subjects with treatment-related adverse events as assessed
Time Frame: Day 1 - Day 28
|
Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed
|
Day 1 - Day 28
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to observed Cmax (Tmax) for D-0120
Time Frame: Day 1 - Day 28
|
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax
|
Day 1 - Day 28
|
Area under the plasma concentration-time curve (AUC) for D-0120
Time Frame: Day 1 - Day 28
|
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive AUC
|
Day 1 - Day 28
|
Maximum Observed Plasma Concentration (Cmax) of D-0120
Time Frame: Day 1 - Day 28
|
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax
|
Day 1 - Day 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 18, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
April 18, 2019
First Submitted That Met QC Criteria
April 18, 2019
First Posted (Actual)
April 23, 2019
Study Record Updates
Last Update Posted (Actual)
May 6, 2022
Last Update Submitted That Met QC Criteria
May 5, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBIO-202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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