MedTrace Logo

Multiple Ascending Dose Study to Assess Safety and Pharmacokinetics of Hemay005 In Healthy Subjects

NCT03570346 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-10-02

No results posted yet for this study

Summary

Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the treatment of psoriasis. A total of approximately 24 subjects will be randomized into 3 cohorts(15mg, 30mg, 60mg), approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose cohort. This study includes an 28-day Screening Period, a 1-day single dose and 7-days multiple doses Treatment Period, and an End of Study Visit occurring approximately 11days (±3 days) after study drug administration.

Conditions

Interventions

DRUG

Hemay005

Subjects will be randomized into 3 dose groups orally twice daily.

DRUG

Placebo

Subjects will be randomized into 3 dose groups orally twice daily.

Sponsors & Collaborators

  • Tianjin Hemay Bio-Tech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Hongyun Wang, Doctor · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2018-10-20
Completion
2018-12-01

Countries

  • China

Study Locations

More Related Trials

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 NCT03570346 on ClinicalTrials.gov