Hyperuricemia or GoutPhase 1/2NCT03923868
D-0120 Safety and PK/PD Study in China
A Phase 1/2 study testing D-0120 in people with Hyperuricemia or Gout, run by InventisBio Co., Ltd at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperuricemia or Gout
- What is being tested?
- D-0120
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesChina
- Study dates
- 18 Apr 2019to 31 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Site 04
Bengbu, Anhui
Site 01- The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang
Site 06
Huzhou, Zhejiang
Site 03
Nanjing, Jiangsu
Site 07
Nanjing, Jiangsu
Site 05
Wenzhou, Zhejiang
About this study
Official title: 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.
- Conditions
- Hyperuricemia or Gout
- Being tested
- D-0120
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0120Drug
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
| Study group | Role | What they receive |
|---|---|---|
| dose escalation in healthy subjects | Experimental | Not described Receives: Drug: D-0120 |
| dose escalation in hyperuricemia patients | Experimental | Not described Receives: Drug: D-0120 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of subjects with treatment-related adverse events as assessed
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
Measured: Day 1 - Day 28
Secondary outcomes (3)
Time to observed Cmax (Tmax) for D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax
Measured: Day 1 - Day 28
Area under the plasma concentration-time curve (AUC) for D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive AUC
Measured: Day 1 - Day 28
Maximum Observed Plasma Concentration (Cmax) of D-0120
Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax
Measured: Day 1 - Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start18 Apr 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperuricemia or GoutStudies of the same condition, open and under way.
- More trials run by InventisBio Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923868
- Sponsor's protocol ID
- IBIO-202
- Status last verified
- May 2022
- First submitted
- 18 Apr 2019
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03923868
- Acronym / sponsor ID
- IBIO-202
- Conditions
- Hyperuricemia or Gout
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dose escalation in healthy subjects | Experimental | Drug: D-0120 |
| dose escalation in hyperuricemia patients | Experimental | Drug: D-0120 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-0120D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days | Drug | dose escalation in healthy subjects, dose escalation in hyperuricemia patients |
Primary outcome
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
3 secondary outcomes
Time to observed Cmax (Tmax) for D-0120
Time frame: Day 1 - Day 28
Area under the plasma concentration-time curve (AUC) for D-0120
Time frame: Day 1 - Day 28
Maximum Observed Plasma Concentration (Cmax) of D-0120
Time frame: Day 1 - Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing D-0120 in people with Hyperuricemia or Gout, run by InventisBio Co., Ltd at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of subjects with treatment-related adverse events as assessed (time frame: Day 1 - Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.