A Multiple Ascending Doses (MAD) Study of PMG1015 in Idiopathic Pulmonary Fibrosis Subjects

Last updated: May 22, 2024
Sponsor: Pulmongene Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Injury

Scar Tissue

Idiopathic Pulmonary Fibrosis

Treatment

PMG1015 placebo

PMG1015

Clinical Study ID

NCT05895565
PMG1015_CHN_Ib
  • Ages 40-85
  • All Genders

Study Summary

This is a phase 1b randomized, double-blind, placebo-controlled, multiple ascending doses (MAD) study of PMG1015 in idiopathic pulmonary fibrosis (IPF) subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after MAD.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Diagnosis of IPF as defined by current American Thoracic Society (ATS)/EuropeanRespiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American ThoracicAssociation (ALAT) Clinical Practice Guidelines for IPF (2022) (Pathologicalexamination refers to transbronchial lung cryobiopsy or surgical/pleuroscopic lungbiopsy);

  2. Forced vital capacity percent predicted (FVCpp) ≥45% at screening;

  3. Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin)from 30% to 90% of the predicted, inclusive at screening;

  4. Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons

Exclusion

Key Exclusion Criteria:

  1. Patients with instable condition of IPF as assessed by the investigator atscreening, and those with acute exacerbation of IPF during screening or within 3months prior to randomization;

  2. Patients who are likely to be lung transplant recipients within 6 months or expectedto survive less than 1 year as assessed by the investigator at screening;

  3. Patients accompanying with an interstitial lung disease other than IPF;

  4. Patients accompanying with other types of respiratory disorders, which may affectthe study results as assessed by the investigator;

  5. Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g.Bosentan) within 1 month prior to screening;

  6. Patients accompanying with other uncontrolled underlying diseases, for which thepatient is not considered suitable for the study as assessed by the investigator;

  7. Patients who had active tuberculosis within 12 months prior to screening, orclinical symptoms of bacterial, viral, fungal or microbial infections requiringintervention within 4 weeks prior to randomization;

  8. Patients who have known allergic reaction to the investigational product or itsactive pharmaceutical ingredients (APIs), or history of allergic reaction to human,humanized, chimeric, or murine monoclonal antibodies or any substances contained inthe excipients;

  9. Pregnant or lactating women; female subjects who plan to become pregnant during thestudy, or patients who are not willing to take contraceptive measures as required bythe protocol during the study;

  10. Other conditions that preclude the patient from participating in the study asassessed by the investigator.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: PMG1015 placebo
Phase: 1
Study Start date:
May 19, 2023
Estimated Completion Date:
May 27, 2025

Connect with a study center

  • Site 07

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230000
    China

    Active - Recruiting

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Site 01

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Site 06

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Site 03

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Tongji Hospital, Tongji Medical College of HUST

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Site 04

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Site 02

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Site 05

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

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