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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pharmacokinetics; Safety
• Intervention / Treatment: Drug: Placebo; Drug: GV-971

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xianliang Xin, Ph D; Phone Number: 1097 +86-21-50504988; Email: xinxianliang@gv-ri.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Recruiting
      • Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital
      • Contact: Chen Yu, MD; Phone Number: +86-21-54036058; Email: clab001@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GV-971 900 mg; 900 mg oral	Drug: GV-971; Oral GV-971; Other Names: Sodium Oligo-mannurarate
EXPERIMENTAL: GV-971 1200 mg; 1200 mg oral	Drug: GV-971; Oral GV-971; Other Names: Sodium Oligo-mannurarate
EXPERIMENTAL: GV-971 1500 mg; 1500 mg oral	Drug: GV-971; Oral GV-971; Other Names: Sodium Oligo-mannurarate
PLACEBO_COMPARATOR: Placebo; Oral placebo	Drug: Placebo; Oral Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Chen Yu, MD, Shanghai Xuhui Center hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2018
• Primary Completion (ANTICIPATED): November 30, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (ACTUAL): October 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: CRC-C1826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No