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

Green Valley Pharmaceuticals

Status and phase: Unknown; Phase 1

Conditions: Safety; Pharmacokinetics

Treatments: Drug: GV-971; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03715114

CRC-C1826

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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45 participants in 4 patient groups, including a placebo group

GV-971 900 mg

Experimental group

Description:

900 mg oral

Treatment:

Drug: GV-971

GV-971 1200 mg

Experimental group

Description:

1200 mg oral

Treatment:

Drug: GV-971

GV-971 1500 mg

Experimental group

Description:

1500 mg oral

Treatment:

Drug: GV-971

Placebo

Placebo Comparator group

Description:

Oral placebo

Treatment:

Drug: Placebo