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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715114
• Other study ID #: CRC-C1826
• Status: Recruiting
• Phase: Phase 1
• Start date: October 15, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2018
• Source: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Contact: Xianliang Xin, Ph D
• Phone: +86-21-50504988
• Email: xinxianliang[@]gv-ri.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetics
• Safety

Intervention

Drug:
• GV-971
Oral GV-971
• Placebo
Oral Placebo

Locations

Country	Name	City	State
China	Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Greenvalley Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Adverse Event (AE)	AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971	7 days