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A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Subjects

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ClinicalTrials.gov Identifier: NCT03715114
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 15, 2018
First Posted Date  ICMJE October 22, 2018
Last Update Posted Date October 22, 2018
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Peak plasma concentration (Cmax) [ Time Frame: 2 day and 7 day ]
    Cmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
  • Half life time (T1/2) [ Time Frame: 2 day and 7 day ]
    T1/2 will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 2 day and 7 day ]
    AUC will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
  • Time to the peak drug concentration (Tmax) [ Time Frame: 2 day and 7 day ]
    Tmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Adverse Event (AE) [ Time Frame: 7 days ]
AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971
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 A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Subjects
Official Title  ICMJE A Double-blind, Randomized, Placebo Controlled Single and Multiple Dose Study to Assess the Safety and Pharmacokinetics of Sodium Oligo-mannurarate (GV-971) Capsule in Healthy Chinese Subjects
Brief Summary To evaluate the safety and pharmacokinetics of GV-971 capsules after oral a single or multiple doses of 900 mg, 1200 mg and 1500 mg in healthy subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Pharmacokinetics
  • Safety
Intervention  ICMJE
  • Drug: GV-971
    Oral GV-971
    Other Name: Sodium Oligo-mannurarate
  • Drug: Placebo
    Oral Placebo
Study Arms  ICMJE
  • Experimental: GV-971 900 mg
    900 mg oral
    Intervention: Drug: GV-971
  • Experimental: GV-971 1200 mg
    1200 mg oral
    Intervention: Drug: GV-971
  • Experimental: GV-971 1500 mg
    1500 mg oral
    Intervention: Drug: GV-971
  • Placebo Comparator: Placebo
    Oral placebo
    Intervention: Drug: Placebo
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: October 19, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy subjects;
  2. Age:≥18 and ≤40 on the date signing informed consent;
  3. Body mass index (BMI): 19-26 kg/m2 and the weight ≥50 kg for male and ≥45 kg for female;
  4. Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.

Exclusion Criteria:

  1. Subjects may be allergic to GV-971 in the opinion of the investigator;
  2. With diseases which could impact on the absorption, distribution, metabolism and excretion (ADME) of study drugs or protocol adherence in the opinion of the investigator (such medical disorder/disease may relate to cardiovascular, liver, kidney, digestive, immune, blood, endocrine, metabolic, cancer, neuropsychiatric,etc );
  3. Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 12 weeks prior to screening;
  4. Participation in any investigational drug or medical instrument study within 3 months prior to screening;
  5. Use of any prescription medicine or herbal remedy, over the counter medication or dietary supplements such as vitamin, calcium within 2 weeks prior to screening;
  6. Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening;
  7. Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening;
  8. Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
  9. Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination;
  10. Positive seurology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test;
  11. Vegetarian or person with dietary restrictions;
  12. Subjects able to father a child are unwilling to use highly effective physical form of birth control from the trial period until 3 months after the completion of study;
  13. Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xianliang Xin, Ph D +86-21-50504988 ext 1097 xinxianliang@gv-ri.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715114
Other Study ID Numbers  ICMJE CRC-C1826
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Greenvalley Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Shanghai Greenvalley Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chen Yu, MD Shanghai Xuhui Center hospital
PRS Account Shanghai Greenvalley Pharmaceutical Co., Ltd.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP