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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2018-12-31

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.

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Detailed Description

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Conditions

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Pharmacokinetics Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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GV-971 900 mg

900 mg oral

Group Type EXPERIMENTAL

GV-971

Intervention Type DRUG

Oral GV-971

GV-971 1200 mg

1200 mg oral

Group Type EXPERIMENTAL

GV-971

Intervention Type DRUG

Oral GV-971

GV-971 1500 mg

1500 mg oral

Group Type EXPERIMENTAL

GV-971

Intervention Type DRUG

Oral GV-971

Placebo

Oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral Placebo

Interventions

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GV-971

Oral GV-971

Intervention Type DRUG

Placebo

Oral Placebo

Intervention Type DRUG

Other Intervention Names

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Sodium Oligo-mannurarate

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes