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

Phase 1

• Conditions: Pharmacokinetics; Safety
• Interventions: Drug: Placebo; Drug: GV-971

• Registration Number: NCT03715114
• Lead Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-15
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-19
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-22
• Primary Completion: 2018-11-30
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral placebo
GV-971 1200 mg	GV-971	1200 mg oral
GV-971 900 mg	GV-971	900 mg oral
GV-971 1500 mg	GV-971	1500 mg oral

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse Event (AE)	7 days	AE occurred after oral 900 mg, 1200 mg and 1500 mg of GV-971

Trial Locations

Locations (1)

Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital; 🇨🇳 Shanghai, Shanghai, China