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A Study of PMG1015 Injection in Idiopathic Pulmonary Fibrosis Subjects

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 40 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 1.
Able to understand the study procedures and method, willing to complete the study as required by the clinical study protocol, and sign the ICF;
  • - 2.
Males or females, aged between 40 and 85 years of age, inclusive at signature of ICF.
  • - 3.
Body weight ≥ 50 kg for males and ≥40 kg for females;
  • - 4.
Diagnosis of IPF (HRCT diagnosis of UIP pattern/probable UIP pattern [as reviewed and confirmed by experts from independent imaging review team] with or without a pathologic diagnosis of UIP pattern/probable UIP pattern; if HRCT diagnosis is indeterminate for UIP, then a pathologic diagnosis of UIP pattern/probable UIP pattern is required) 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);
  • - 5.
Forced vital capacity percent predicted (FVCpp) ≥45% at screening;
  • - 6.
Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
  • - 7.
Patients not receiving any approved IPF treatment (Pirfenidone or Nintedanib) for any reasons within 1 month before randomization, including those who were not tolerant or responsive to prior treatment with approved drugs (Pirfenidone or Nintedanib), or those who disagree to receive the approved IPF treatment after discussion with the investigator on the risks or benefits of such medications (Note: It's not allowed for any subject to discontinue the approved IPF treatment for inclusion into this study).

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 with range of emphysema more than that of pulmonary fibrosis as indicated by chest HRCT (conclusion from independent imaging review shall prevail) at screening;
  • - 4.
Patients accompanying with obstructive airway diseases (such as FEV1/FVC < 0.7 after bronchodilator therapy);
  • - 5.
Patients accompanying with an interstitial lung disease other than IPF;
  • - 6.
Patients accompanying with other types of respiratory disorders, which may affect the study results as assessed by the investigator;
  • - 7.
Patients who require ≥ 15 hours of daily oxygen therapy;
  • - 8.
Oxygen saturation at rest in room air measured by a finger pulse oximeter <90% (0-1500 meters above the sea level) or <85% (>1500 meters above the sea level) at screening;
  • - 9.
Patients who received corticosteroids (Prednisone Acetate Tablets > 15 mg/day or an equivalent dose of other corticosteroids) within 1 month prior to screening;
  • - 10.
Patients who received any cytotoxic drug, immunosuppressant, cytokine regulator, or receptor antagonist (including but not limited to Methotrexate, Azathioprine, Mycophenolate Mofetil, Cyclophosphamide, Cyclosporin) within 4 weeks prior to screening;
  • - 11.
Patients who received vasodilator therapy for pulmonary arterial hypertension (e.g. Bosentan) within 1 month prior to screening;
  • - 12.
Patients accompanying with other uncontrolled underlying diseases (congestive heart failure, acute myocardial infarction, unstable angina pectoris, hemorrhagic stroke, or ischemic stroke categorized as New York Heart Association [NYHA] Class III, or IV, as well as pulmonary arterial hypertension requiring intervention within 6 months prior to screening), for which the patient is not considered suitable for the study as assessed by the investigator;
  • - 13.
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;
  • - 14.
Patients with coronavirus disease-2019 (COVID-19) diagnosis within 1 month prior to screening and/or at screening (COVID-19 nucleic acid test is not a required procedure of the study, but may be performed if necessary);
  • - 15.
Patients who were vaccinated or plan to get vaccinated against COVID-19 and other diseases within 1 month prior to screening and up to 1 month after the last dose;
  • - 16.
Patients with history of malignancies (excluding recovered basal cell carcinoma and cervical carcinoma in situ) within 5 years prior to screening, or under evaluation of any potential malignancies;
  • - 17.
Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2×Upper Limit of Normal (ULN) or Total Bilirubin ≥1.5×ULN;
  • - 18.
Serum creatinine ≥1.5×ULN;
  • - 19.
Patients with active hepatitis, syphilis, or positive for HIV antibody;
  • - 20.
Patients who had a major surgery (under general anesthesia) within 3 months prior to screening, or plan to undergo a surgery during the study, which may affect the evaluation of the study endpoints as assessed by the investigator;
  • - 21.
Patients who participated in any clinical trials (of, including, other investigational drugs/devices) within 3 months prior to screening, or within 5 half-lives at screening;
  • - 22.
A former smoker who quitted for ≤ 3 months, or unable to quit smoking throughout the study;
  • - 23.
A suspected or confirmed alcohol or drug abuser;
  • - 24.
Patients who have known allergic reaction to the investigational product or its APIs, or history of allergic reaction to human, humanized, chimeric, or murine monoclonal antibodies or any substances contained in the excipients;
  • - 25.
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;
  • - 26.
Other conditions that preclude the patient from participating in the study as assessed by the investigator.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pulmongene Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chen Wang, PhDHuaping Dai, PhD
Principal Investigator Affiliation China-Japan Friendship HospitalChina-Japan Friendship Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Arms & Interventions


Experimental: Experimental

Including 3 dose groups (15 mg/kg, 30 mg/kg and 40 mg/kg), with 10 subjects (8 of whom receiving the investigational product) enrolled into each group. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.

Placebo Comparator: Placebo Comparator

Including 3 dose groups (15 mg/kg, 30 mg/kg and 40 mg/kg), with 10 subjects (2 of whom receiving placebo) enrolled into each group. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.


Drug: - PMG1015

Strength: 100 mg/2 mL/vial. Dosage and Administration: Intravenous infusion of PMG1015 at 15 mg/kg, 30 mg/kg and 40 mg/kg for 30 min (±5 min), once every 4 weeks, for 3 doses.

Drug: - PMG1015 placebo

The placebo injection of PMG1015 contains the same excipients as PMG1015 Injection, only without the active substance. Strength: 2 mL/vial. Dosage and Administration: A single dose of placebo. Intravenous infusion for 30 min (±5 min), once every 4 weeks, for 3 doses.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hefei, Anhui, China




The Second Hospital of Anhui Medical University

Hefei, Anhui, 230000

Site Contact

Hui Zhao, Master



China-Japan Friendship Hospital, Beijing, Beijing, China




China-Japan Friendship Hospital

Beijing, Beijing, 100029

Site Contact

Siyuan Xi



Guangzhou, Guangdong, China




The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120

Site Contact

Qun Luo, PhD



Wuhan, Hubei, China




Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430030

Site Contact

Huilan Zhang, PhD



Nanjing Drum Tower Hospital, Nanjing, Jiangsu, China




Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008

Site Contact

Mengshu Cao, PhD



Shanghai Chest Hospital, Shanghai, Shanghai, China




Shanghai Chest Hospital

Shanghai, Shanghai, 200030

Site Contact

Feng Li, PhD



Shanghai Pulmonary Hospital, Shanghai, Shanghai, China




Shanghai Pulmonary Hospital

Shanghai, Shanghai, 200433

Site Contact

Jinfu Xu, PhD