Clinical trial NCT03715114: A Study to Assess the Safety and Pharmacokinetics of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Subjects
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Safety
Lead sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-10-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Peak plasma concentration (Cmax)
timeFrame: 2 day and 7 day
measure: Half life time (T1/2)
timeFrame: 2 day and 7 day
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 2 day and 7 day
measure: Time to the peak drug concentration (Tmax)
timeFrame: 2 day and 7 day
Secondary outcomes:
measure: Adverse Event (AE)
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital
state: Shanghai
Study officials:
affiliation: Shanghai Xuhui Center hospital
name: Chen Yu, MD
role: PRINCIPAL_INVESTIGATOR
References: