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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pharmacokinetics, Safety

Intervention / Treatment
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* Drug: GV-971
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GV-971 900 mg<br>900 mg oral | Drug: GV-971<br>* Oral GV-971<br>* Other names: Sodium Oligo-mannurarate;|
| Experimental: GV-971 1200 mg<br>1200 mg oral | Drug: GV-971<br>* Oral GV-971<br>* Other names: Sodium Oligo-mannurarate;|
| Experimental: GV-971 1500 mg<br>1500 mg oral | Drug: GV-971<br>* Oral GV-971<br>* Other names: Sodium Oligo-mannurarate;|
| Placebo Comparator: Placebo<br>Oral placebo | Drug: Placebo<br>* Oral Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak plasma concentration (Cmax) | Cmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day | 
| Half life time (T1/2) | T1/2 will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day | 
| Area under the plasma concentration versus time curve (AUC) | AUC will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day | 
| Time to the peak drug concentration (Tmax) | Tmax will be determined after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 2 day and 7 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event (AE) | AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971 | 7 days |