Condition or disease | Intervention/treatment | Phase |
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Hyperuricemia or Gout | Drug: D-0120 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 18, 2019 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | December 31, 2021 |
Arm | Intervention/treatment |
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Experimental: dose escalation in healthy subjects |
Drug: D-0120
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
|
Experimental: dose escalation in hyperuricemia patients |
Drug: D-0120
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
|
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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:
Exclusion Criteria:
Contact: Zhe Shi, PhD | +86 21-50663661 | zhe.shi@inventisbio.com |
China, Anhui | |
Site 04 | Recruiting |
Bengbu, Anhui, China | |
Contact: Site 04 | |
China, Jiangsu | |
Site 03 | Recruiting |
Nanjing, Jiangsu, China | |
Contact: Site 03 | |
Site 07 | Recruiting |
Nanjing, Jiangsu, China | |
Contact: Site 07 | |
China, Zhejiang | |
Site 01- The second affiliated hospital of zhejiang university school of medicine | Recruiting |
Hangzhou, Zhejiang, China | |
Contact: Site 01 | |
Site 06 | Recruiting |
Huzhou, Zhejiang, China | |
Contact: Site 06 | |
Site 05 | Recruiting |
Wenzhou, Zhejiang, China | |
Contact: Site 05 |
Tracking Information | |||||
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First Submitted Date ICMJE | April 18, 2019 | ||||
First Posted Date ICMJE | April 23, 2019 | ||||
Last Update Posted Date | September 29, 2020 | ||||
Actual Study Start Date ICMJE | April 18, 2019 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | D-0120 Safety and PK/PD Study in China | ||||
Official Title ICMJE | 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 | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Hyperuricemia or Gout | ||||
Intervention ICMJE | Drug: D-0120
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2021 | ||||
Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03923868 | ||||
Other Study ID Numbers ICMJE | IBIO-202 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | InventisBio Inc. | ||||
Study Sponsor ICMJE | InventisBio Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | InventisBio Inc. | ||||
Verification Date | September 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |