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Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers

NCT04714294 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-01-19

No results posted yet for this study

Summary

Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease characterized by persistent respiratory symptoms and incompletely reversible airflow limitation. It is usually caused by airway and / or alveolar abnormalities caused by obvious exposure to toxic particles or gases.COPD is currently the fourth leading cause of death in the world, and is expected to be the third leading cause of death by 2020.HPP737 as an oral PDE4 inhibitor for the treatment of COPD.Preclinical data showed that the activity of HPP737 was similar to that of rofloxacin, but HPP737 significantly reduced the permeability to CNS and may have better tolerance. HPP737 will be used to develop indications for chronic obstructive pulmonary disease, and PK study in Chinese people is going to to evaluate the safety and tolerability of HPP737 in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

HPP737 or placebo

HPP737 or placebo will be randomized to assign to subjects

Sponsors & Collaborators

  • Newsoara Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Nengming Lin, Dr · Hangzhou, Zhejiang Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • China

Study Locations

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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 NCT04714294 on ClinicalTrials.gov