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

NCT03715114 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-10-22

No results posted yet for this study

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

Interventions

DRUG

GV-971

Oral GV-971

DRUG

Placebo

Oral Placebo

Sponsors & Collaborators

  • Shanghai Greenvalley Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen Yu, MD · Shanghai Xuhui Center hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2018-11-30
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715114 on ClinicalTrials.gov