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

• Status: Unknown status
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.

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.