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

NCT05895565 | Completed Phase 1

• 1 other identifier: PMG1015_CHN_Ib
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (9)

• The incidence of treatment-emergent adverse events (TEAEs)

  An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occur following the start of treatment.

  Approximately 170 days.

• The severity of treatment-emergent adverse events (TEAEs)

  Severity of TEAEs (Grade 1 to 5) will be assessed based on NCI-CTCAE V5.0.

  Approximately 170 days.

• The incidence of serious adverse events (SAEs)

  A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of medicinal product that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or results in congenital anomaly/birth defect.

  Approximately 170 days.

• The severity of serious adverse events (SAEs)

  A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of medicinal product that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or results in congenital anomaly/birth defect.

  Approximately 170 days.

• Assessment of pulmonary function test results-forced vital capacity (FVC)

  Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced vital capacity (FVC) (mL) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FVC from baseline to post-dose.

  Approximately 170 days.

• Assessment of pulmonary function test results-forced vital capacity percent predicted (FVCpp)

  Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced vital capacity percent predicted (FVCpp) (%) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FVCpp from baseline to post-dose.

  Approximately 170 days.

• Assessment of pulmonary function test results-forced expiratory volume in 1 second (FEV1)

  Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Forced expiratory volume in 1 second (FEV1) (L) will be measured at Visits 1, 8, 14 and 16, to assess the changes in FEV1 from baseline to post-dose.

  Approximately 170 days.

• Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide (DLCO)

  Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Diffusing capacity of the lungs for carbon monoxide (DLCO) (mL/min/mmHg) will be measured at Visits 1, 8, 14 and 16, to assess the changes in DLCO from baseline to post-dose.

  Approximately 170 days.

• Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp)

  Pulmonary function test is a test to explore the functional status of human respiratory system with the knowledge of exercise respiratory physiology and modern examination technology. Diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) (DLCO%) will be measured at Visits 1, 8, 14 and 16, to assess the changes in DLCOpp from baseline to post-dose.

  Approximately 170 days.

Secondary Outcomes (11)

• Evaluate the area under the serum drug concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of PMG1015.

  Approximately 170 days.

• Evaluate the area under the serum drug concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015.

  Approximately 170 days.

• Evaluate the area under the concentration-time curve from time zero to the end of a dosing interval (AUC0-tau) of PMG1015.

  Approximately 170 days.

• Evaluate the maximum concentration (Cmax) of PMG1015.

  Approximately 170 days.

• Evaluate the time to reach the maximum concentration (Tmax) of PMG1015.

  Approximately 170 days.

Study Arms (2)

PMG1015

EXPERIMENTAL

Drug: PMG1015

Placebo Comparator

PLACEBO COMPARATOR

Drug: PMG1015 placebo

Interventions

PMG1015 DRUG

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

PMG1015

PMG1015 placebo DRUG

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

Placebo Comparator

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
• Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
• Subjects not receiving any approved IPF treatment (pirfenidone or nintedanib) within 1 month before enrollment for any reasons

You may not qualify if:

• 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;
• 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;
• Patients accompanying with an interstitial lung disease other than IPF;
• Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator;
• Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening;
• Patients accompanying with other uncontrolled underlying diseases, for which the patient is not considered suitable for the study as assessed by the investigator;
• 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;
• 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;
• 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;
• Other conditions that preclude the patient from participating in the study as assessed by the investigator.

Sponsors & Collaborators

• Pulmongene Ltd.: lead

Study Sites (7)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Officials

• Wang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Dai

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: June 8, 2023
• Study Start: May 19, 2023
• Primary Completion: February 7, 2025
• Study Completion: February 7, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)