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出境医 / 临床实验 / D-0120 Safety and PK/PD Study in China

D-0120 Safety and PK/PD Study in China

Study Description
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.

Condition or disease Intervention/treatment Phase
Hyperuricemia or Gout Drug: D-0120 Phase 1 Phase 2

Study Design
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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
Arms and Interventions
Arm Intervention/treatment
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

Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old and ≤ 65 years old;
  2. 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:

  3. Subject's BMI range is 18.0~32.0 kg/m2 (inclusive);
  4. 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;
  5. 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.
  6. Subjects have the ability to follow study and follow-up procedures.
  7. 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:

  1. 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;
  2. Allergic constitution, or allergy to any drug used in the study or any ingredient of study drug;
  3. History of malignant tumors;
  4. 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);
  5. Urinary calculi confirmed by B-ultrasound during screening period;
  6. 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;
  7. Participation in clinical studies of any investigational drugs or medical devices within 3 months prior to screening;
  8. Major surgery within 3 months prior to randomization;
  9. Any clinically significant acute diseases within one month prior to screening at the discretion of the investigators;
  10. Gout flare within 14 days prior to randomization;
  11. Use of other uric acid-lowering drugs (allopurinol, febuxostat, probenecid, benzbromarone) within 14 days prior to randomization;
  12. Daily dose of aspirin > 100 mg within 14 days before randomization;
  13. Use of any diuretic within 14 days before randomization;
  14. Use of any Chinese herbal medicine within 14 days before randomization;
  15. History of drug abuse or alcohol abuse (for phase Ib healthy subjects, the screening alcohol test and urine drug test are positive);
  16. Any situation that may prevent the subject from completing the study or pose a significant risk to the subject as considered by any investigator;
  17. Any other situation that may pose excessive risks to the subject or affect outcome or study interpretation as considered by any investigator;
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Zhe Shi, PhD +86 21-50663661 zhe.shi@inventisbio.com

Locations
Layout table for location information
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         
Sponsors and Collaborators
InventisBio Inc.
Tracking Information
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
 (submitted: April 18, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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
  • 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
  • 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
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
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hyperuricemia or Gout
Intervention  ICMJE Drug: D-0120
D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
Study Arms  ICMJE
  • Experimental: dose escalation in healthy subjects
    Intervention: Drug: D-0120
  • Experimental: dose escalation in hyperuricemia patients
    Intervention: Drug: D-0120
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
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:

  1. Age ≥ 18 years old and ≤ 65 years old;
  2. 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:

  3. Subject's BMI range is 18.0~32.0 kg/m2 (inclusive);
  4. 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;
  5. 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.
  6. Subjects have the ability to follow study and follow-up procedures.
  7. 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:

  1. 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;
  2. Allergic constitution, or allergy to any drug used in the study or any ingredient of study drug;
  3. History of malignant tumors;
  4. 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);
  5. Urinary calculi confirmed by B-ultrasound during screening period;
  6. 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;
  7. Participation in clinical studies of any investigational drugs or medical devices within 3 months prior to screening;
  8. Major surgery within 3 months prior to randomization;
  9. Any clinically significant acute diseases within one month prior to screening at the discretion of the investigators;
  10. Gout flare within 14 days prior to randomization;
  11. Use of other uric acid-lowering drugs (allopurinol, febuxostat, probenecid, benzbromarone) within 14 days prior to randomization;
  12. Daily dose of aspirin > 100 mg within 14 days before randomization;
  13. Use of any diuretic within 14 days before randomization;
  14. Use of any Chinese herbal medicine within 14 days before randomization;
  15. History of drug abuse or alcohol abuse (for phase Ib healthy subjects, the screening alcohol test and urine drug test are positive);
  16. Any situation that may prevent the subject from completing the study or pose a significant risk to the subject as considered by any investigator;
  17. Any other situation that may pose excessive risks to the subject or affect outcome or study interpretation as considered by any investigator;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Zhe Shi, PhD +86 21-50663661 zhe.shi@inventisbio.com
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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