ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 287619 for:    ALL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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.

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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Safety Drug: GV-971 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: GV-971 900 mg
900 mg oral
Drug: GV-971
Oral GV-971
Other Name: Sodium Oligo-mannurarate

Experimental: GV-971 1200 mg
1200 mg oral
Drug: GV-971
Oral GV-971
Other Name: Sodium Oligo-mannurarate

Experimental: GV-971 1500 mg
1500 mg oral
Drug: GV-971
Oral GV-971
Other Name: Sodium Oligo-mannurarate

Placebo Comparator: Placebo
Oral placebo
Drug: Placebo
Oral Placebo




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Adverse Event (AE) [ Time Frame: 7 days ]
    AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715114


Contacts
Contact: Xianliang Xin, Ph D +86-21-50504988 ext 1097 xinxianliang@gv-ri.com

Locations
China, Shanghai
Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital Recruiting
Shanghai, Shanghai, China, 200031
Contact: Chen Yu, MD    +86-21-54036058    clab001@126.com   
Sponsors and Collaborators
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Chen Yu, MD Shanghai Xuhui Center hospital

Responsible Party: Shanghai Greenvalley Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03715114     History of Changes
Other Study ID Numbers: CRC-C1826
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No