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

NCT ID: NCT05895565

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-19
• Study Completion Date: 2025-02-07

Brief 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.

Conditions

IPF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PMG1015

Group Type: EXPERIMENTAL

PMG1015

Intervention Type: DRUG

Including 3 dose levels: level 1, level 2 and level 3

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

PMG1015 placebo

Intervention Type: DRUG

Including 2 dose levels corresponding to PMG1015 level 1 and level 2, with no placebo group set for PMG1015 level 3

Interventions

PMG1015

Including 3 dose levels: level 1, level 2 and level 3

Intervention Type: DRUG

PMG1015 placebo

Including 2 dose levels corresponding to PMG1015 level 1 and level 2, with no placebo group set for PMG1015 level 3

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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 Criteria

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

2. Patients who are likely to be lung transplant recipients within 6 months or expected to 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 affect the 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 the patient is not considered suitable for the study as assessed by the investigator;

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

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

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

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pulmongene Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wang

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Dai

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

PMG1015_CHN_Ib

Identifier Type: -

Identifier Source: org_study_id