IPF Clinical Trial - A Study of PMG1015 Injection in Idiopathic Pulmonary

Status Recruiting

Clinical Trial Summary

Idiopathic Pulmonary Fibrosis (IPF): It is a progressive and fatal fibrosing interstitial lung disease of unknown etiology, with a median survival of only 2 to 3 years. Epidemiology of IPF (with reference to the international epidemiological studies due to the lack of accurate epidemiological data in China): the incidence was 2 to 30 per 100,000 person years, and the prevalence was 10 to 60 per 100,000. More males suffer from IPF than females. In population aged more than 65 years, the estimated prevalence was up to 400 per 100,000. Medications for IPF: Currently there is no medication with definitely significant efficacy (such as slowing down the disease progression). However, the following drugs can be used as appropriate based on the results of randomized and controlled clinical trials conducted in recent years and taking account of the patients' actual clinical conditions. Pirfenidone: It has been proven to remarkably slow down forced vital capacity (FVC) decline and reduce the risk of death to a certain degree, with the side effects of photosensitivity, asthenia, rash, stomach upset, and anorexia. Pirfenidone is recommended for IPF patients accompanying with mild to moderate pulmonary dysfunction in clinical practice. Nintedanib: It could remarkably slow down the absolute value of FVC decline in IPF patients, thereby slowing down the disease progression to a certain degree. The most common adverse reaction of Nintedanib is diarrhoea. Future therapeutic strategies for IPF: A multi-drug concomitant therapy against different therapeutic targets for pulmonary fibrosis may be a potential strategy, among which, the research and development of anti-fibrotic drugs may be most valuable in treatment of this disease, with promising potentials of halting or reversing disease progression, extending the life expectancy, improving the quality of life, and reducing the side effects.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05895565
Study type	Interventional
Source	Pulmongene Ltd.
Contact	Yaohui Wang, BA
Phone	86-010-69776688
Email	yaohui_wang@pulmongene.com
Status	Recruiting
Phase	Phase 1
Start date	May 19, 2023
Completion date	May 27, 2025

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study of PMG1015 Injection in Idiopathic Pulmonary Fibrosis Subjects

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms