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

NCT03715114 | Unknown Phase 1

• 1 other identifier: CRC-C1826
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics; Safety

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Adverse Event (AE)

  7 days

Study Arms (4)

GV-971 900 mg

EXPERIMENTAL

900 mg oral

Drug: GV-971

GV-971 1200 mg

EXPERIMENTAL

1200 mg oral

Drug: GV-971

GV-971 1500 mg

EXPERIMENTAL

1500 mg oral

Drug: GV-971

Placebo

PLACEBO COMPARATOR

Oral placebo

Drug: Placebo

Interventions

GV-971 DRUG

Oral GV-971

Also known as: Sodium Oligo-mannurarate

GV-971 1200 mg; GV-971 1500 mg; GV-971 900 mg

Placebo DRUG

Oral Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects;
• Age：≥18 and ≤40 on the date signing informed consent;
• Body mass index (BMI): 19-26 kg/m2 and the weight ≥50 kg for male and ≥45 kg for female；
• Subjects are able to understand the study procedures and methods, and willing to strictly comply with the protocol and give written informed consent.

You may not qualify if:

• Subjects may be allergic to GV-971 in the opinion of the investigator;
• 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 );
• Blood donation of ≥400 mL or severe blood lose and the volume of blood loss ≥400 mL within 12 weeks prior to screening;
• Participation in any investigational drug or medical instrument study within 3 months prior to screening;
• 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;
• Smoking more than 10 cigarettes a day, drugs or alcohol abuse within 6 months prior to screening;
• Use of heparin, alginic sodium diester , mannose ester within 4 weeks prior to screening；
• Clinically significant abnormalities in physical examination and laboratory test results or 12-lead ECG, etc. in screening;
• Clinically significant abnormalities in Chest X-ray or abdominal B-ultrasound examination;
• Positive seurology screen for Hepatitis B( HBsAg), Hepatitis C(HCV), HIV and USR unheated serum reagin test;
• Vegetarian or person with dietary restrictions;
• 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;
• Any other reasons that the subject is not eligible for participation in the study in the opinion of the investigator.

Sponsors & Collaborators

• Shanghai Greenvalley Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Phase-I Clinical Research Unit at Shanghai Xuhui Center hospital

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

MeSH Terms

Interventions

GV-971

Study Officials

• Chen Yu, MD

  Shanghai Xuhui Center hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianliang Xin, Ph D

CONTACT

+86-21-50504988; xinxianliang@gv-ri.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 22, 2018
• Study Start: October 15, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: October 22, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)