Pharmacokinetics, Safety
Conditions
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.
Interventions
DRUGGV-971
Oral GV-971
DRUGPlacebo
Oral Placebo
Sponsors
Shanghai Greenvalley Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plasma concentration (Cmax) | 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) | 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) | 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) | 2 day and 7 day | Tmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event (AE) | 7 days | AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971 |
Countries
China
Contacts
Primary ContactXianliang Xin, Ph D
Outcome results
None listed