A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Subjects
Study Details
Study Description
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 |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GV-971 900 mg 900 mg oral |
Drug: GV-971
Oral GV-971
Other Names:
|
| Experimental: GV-971 1200 mg 1200 mg oral |
Drug: GV-971
Oral GV-971
Other Names:
|
| Experimental: GV-971 1500 mg 1500 mg oral |
Drug: GV-971
Oral GV-971
Other Names:
|
| Placebo Comparator: Placebo Oral placebo |
Drug: Placebo
Oral Placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Adverse Event (AE) [7 days]
AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy subjects;
-
Age：≥18 and ≤40 on the date signing informed consent;
-
Body mass index (BMI): 19-26 kg/m2 and the weight ≥50 kg for male and ≥45 kg for female；
-
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:
-
Subjects may be allergic to GV-971 in the opinion of the investigator;
-
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 );
-
Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 12 weeks prior to screening;
-
Participation in any investigational drug or medical instrument study within 3 months prior to screening;
-
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;
-
Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening;
-
Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening；
-
Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
-
Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination;
-
Positive seurology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test;
-
Vegetarian or person with dietary restrictions;
-
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;
-
Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Shanghai Greenvalley Pharmaceutical Co., Ltd.
Investigators
- Principal Investigator: Chen Yu, MD, Shanghai Xuhui Center hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRC-C1826