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PhaseⅠFirst-in-Human Study of Hemay007 in Healthy Volunteers

NCT02603185 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2017-10-24

No results posted yet for this study

Summary

This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.

Conditions

Interventions

DRUG

Hemay007

DRUG

placebo

Sponsors & Collaborators

  • Tianjin Hemay Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Hemay Pharmaceutical PTY. LTD.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-09
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

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 NCT02603185 on ClinicalTrials.gov