A Study of PMG1015 Injection in Idiopathic Pulmonary Fibrosis Subjects
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
| 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 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.
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) occurring during the study [Throughout the study，approximately 2 years.]
Based on the currently available non-clinical data and disclosed clinical data, the adverse events that may occur during the study include: Infusion-related hypersensitivity reaction; Headache; Symptoms of the digestive system: Nausea, diarrhoea; Elevated liver enzymes: Alanine aminotransferase (ALT) increased, Aspartate aminotransferase (AST) increased, and Gamma-glutamyl transpeptidase increased; Abnormal blood lipids: Blood triglycerides increased; Other unexpected adverse reactions. Criteria for Serious Adverse Events (SAEs): Results in death Is life-threatening Requires or prolongs hospitalization Causes persistent or significant disability or incapacity Results in congenital anomalies or birth defects Death due to disease progression Important medical event
- Assessment of vital sign measurement results-respiratory rate [Throughout the study，approximately 2 years.]
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in respiratory rate (breaths/min).
- Assessment of vital sign measurement results-pulse rate [Throughout the study，approximately 2 years.]
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in pulse rate (beats/min).
- Assessment of vital sign measurement results-body temperature [Throughout the study，approximately 2 years.]
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in body temperature (℃).
- Assessment of vital sign measurement results-sitting blood pressure [Throughout the study，approximately 2 years.]
Vital signs will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in sitting blood pressure (mmHg).
- Title: Title: Assessment of Physical Examination results - skin [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in skin (normal, abnormal).
- Title: Assessment of Physical Examination results - head [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in head (normal, abnormal).
- Title: Assessment of Physical Examination results - neck [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in neck (normal, abnormal).
- Assessment of Physical Examination results - oral cavity [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in oral cavity (normal, abnormal).
- Assessment of Physical Examination results - chest [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in chest (normal, abnormal).
- Assessment of Physical Examination results - abdomen [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in abdomen (normal, abnormal).
- Assessment of Physical Examination results - lymph nodes [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in lymph nodes (normal, abnormal).
- Assessment of Physical Examination results - neurological [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in neurological (normal, abnormal).
- Assessment of Physical Examination results - psychiatric status [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in psychiatric status (normal, abnormal).
- Assessment of Physical Examination results - extremities [Throughout the study，approximately 2 years.]
Physical Examination will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in extremities (normal, abnormal).
- Assessment of Physical Examination results - weight [Throughout the study，approximately 2 years.]
Physical examination will be performed at screening and each dose, to assess the changes from baseline to post-dose in weight (kilograms).
- Assessment of Physical Examination results - height [Throughout the study，approximately 2 years.]
Physical examination will be performed at screening and each dose, to assess the changes from baseline to post-dose in height (meters).
- Assessment of 12-lead electrocardiogram (ECG) results - heart rate [Throughout the study，approximately 2 years.]
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in heart rate (beats per minute).
- Assessment of 12-lead electrocardiogram (ECG) results - RR interval [Throughout the study，approximately 2 years.]
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in RR interval (milliseconds).
- Assessment of 12-lead electrocardiogram (ECG) results - PR interval [Throughout the study，approximately 2 years.]
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in PR interval (milliseconds).
- Assessment of 12-lead electrocardiogram (ECG) results - QRS complex [Throughout the study，approximately 2 years.]
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in QRS complex (milliseconds).
- Assessment of 12-lead electrocardiogram (ECG) results - QTc interval [Throughout the study，approximately 2 years.]
Three ECG scans should be taken at the same time point, with no more than 2 minutes between scans.12-lead electrocardiogram (ECG) will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in QTc interval (milliseconds).
- Assessment of Hematology results - blood cell counts [Throughout the study，approximately 2 years.]
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in blood cell counts (cells/μL).
- Assessment of Hematology results - white blood cell differential counts [Throughout the study，approximately 2 years.]
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in white blood cell differential counts (including eosinophil count and percentage, basophil count and percentage, neutrophil count and percentage, lymphocyte and monocyte count and percentage).
- Assessment of Hematology results - red blood cell count [Throughout the study，approximately 2 years.]
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in red blood cell count (cells/μL).
- Assessment of Hematology results - hematocrit [Throughout the study，approximately 2 years.]
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in hematocrit (%).
- Assessment of Hematology results - hemoglobin content [Throughout the study，approximately 2 years.]
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in hemoglobin content (g/dL).
- Assessment of Hematology results - platelet count [Throughout the study，approximately 2 years.]
Hematology will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in platelet count (cells/μL).
- Assessment of Urinalysis results - pH [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in pH.
- Assessment of Urinalysis results - specific gravity [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in specific gravity.
- Assessment of Urinalysis results - protein [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in protein (negative/+/++/+++).
- Assessment of Urinalysis results - glucose [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in glucose (negative/+/++/+++).
- Assessment of Urinalysis results - ketones [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in ketones (negative/+/++/+++).
- Assessment of Urinalysis results - red blood cells [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in red blood cells (cells/HP).
- Assessment of Urinalysis results - white blood cells [Throughout the study，approximately 2 years.]
Urinalysis will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in white blood cells (cells/HP).
- Assessment of Blood biochemistry results - blood glucose [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in blood glucose (mmol/L).
- Assessment of Blood biochemistry results - triglycerides [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in triglycerides (mmol/L).
- Assessment of Blood biochemistry results - total cholesterol [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total cholesterol (mmol/L).
- Assessment of Blood biochemistry results - direct bilirubin [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in direct bilirubin (μmol/L).
- Assessment of Blood biochemistry results - alanine aminotransferase [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in alanine aminotransferase (ALT,U/L).
- Assessment of Blood biochemistry results - albumin quantification [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in albumin quantification (g/dL).
- Assessment of Blood biochemistry results - total bilirubin [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total bilirubin (μmol/L).
- Assessment of Blood biochemistry results - creatinine [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatinine (μmol/L).
- Assessment of Blood biochemistry results - urea/urea nitrogen [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in urea/urea nitrogen (mmol/L).
- Assessment of Blood biochemistry results - uric acid [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in uric acid (μmol/L).
- Assessment of Blood biochemistry results - potassium [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in potassium (mmol/L).
- Assessment of Blood biochemistry results - sodium [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in sodium (mmol/L).
- Assessment of Blood biochemistry results - chloride [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in chloride (mmol/L).
- Assessment of Blood biochemistry results - total calcium [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in total calcium (mmol/L).
- Assessment of Blood biochemistry results - inorganic phosphorus [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in inorganic phosphorus (mmol/L).
- Assessment of Blood biochemistry results - creatine kinase [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatine kinase (CK,U/L).
- Assessment of Blood biochemistry results - creatine kinase-MB [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in creatine kinase-MB (CK-MB,ng/mL).
- Assessment of Blood biochemistry results - troponin I [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in troponin I (TnI,ng/mL).
- Assessment of Blood biochemistry results - myoglobin [Throughout the study，approximately 2 years.]
Blood biochemistry will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in myoglobin (ng/mL).
- Assessment of Coagulation results- prothrombin time [Throughout the study，approximately 2 years.]
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in prothrombin time (PT, seconds).
- Assessment of Coagulation results- activated partial thromboplastin time [Throughout the study，approximately 2 years.]
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in activated partial thromboplastin time (APTT, seconds).
- Assessment of Coagulation results- international normalized ratio [Throughout the study，approximately 2 years.]
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in international normalized ratio (INR).
- Assessment of Coagulation results- fibrinogen [Throughout the study，approximately 2 years.]
Coagulation will be measured at screening and each follow-up visit, to access the changes from baseline to post-dose in fibrinogen (mg/dL).
- Assessment of pulmonary function test results-forced vital capacity (FVC) [Throughout the study，approximately 2 years.]
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. The changes from baseline to post-dose in forced vital capacity (FVC) (L) will be assessed at baseline and the second dose, and after the last dose.
- Assessment of pulmonary function test results-forced vital capacity percent predicted (FVCpp) [Throughout the study，approximately 2 years.]
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. The changes from baseline to post-dose in forced vital capacity percent predicted (FVCpp) (%) will be assessed at baseline and the second dose, and after the last dose.
- Assessment of pulmonary function test results-forced expiratory volume in 1 second (FEV1) [Throughout the study，approximately 2 years.]
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. The changes from baseline to post-dose in forced expiratory volume in 1 second (FEV1) (L) will be assessed at baseline and the second dose, and after the last dose.
- Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide (DLCO) [Throughout the study，approximately 2 years.]
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. The changes from baseline to post-dose in diffusing capacity of the lungs for carbon monoxide (DLCO) (mL/min/mmHg) will be assessed at baseline and the second dose, and after the last dose.
- Assessment of pulmonary function test results-diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) [Throughout the study，approximately 2 years.]
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. The changes from baseline to post-dose in diffusing capacity of the lungs for carbon monoxide percent predicted (DLCOpp) (DLCO%) will be assessed at baseline and the second dose, and after the last dose.
- Evaluate chest high-resolution computed tomography (HRCT) results. [Throughout the study，approximately 2 years.]
Chest HRCT is a type of CT used for diagnosing diseases of the chest. The HRCT diagnosis should include UIP-type/maybe UIP-type (confirmed by an independent imaging review group expert) with or without pathological UIP-type/maybe UIP-type; non-definitive UIP diagnosed by HRCT requires pathological UIP-type/maybe UIP-type (pathology refers to cryopreserved lung biopsy or surgical/thoracoscopic lung biopsy). Chest HRCT will be performed at screening and each dose, and after the last dose, to assess the changes from baseline to post-dose in Chest HRCT.
Secondary Outcome Measures
- Evaluate the pharmacokinetic (PK) parameter of the area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of PMG1015. [Throughout the study，approximately 2 years.]
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
- Evaluate the PK parameter of the area under the concentration-time curve from time zero to infinity (AUC0-∞) of PMG1015. [Throughout the study，approximately 2 years.]
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
- Evaluate the PK parameter of the area under the concentration-time curve from time zero to the dosing interval (AUC0-tau) of PMG1015. [Throughout the study，approximately 2 years.]
AUC is a pharmacokinetic parameter that represents the concentration of a drug in the blood at a certain time.
- Evaluate the PK parameter of the maximum concentration (Cmax) of PMG1015. [Throughout the study，approximately 2 years.]
Cmax refers to the highest concentration of a drug in the blood after administration, which is related to the dose, route of administration, dosing frequency, and time to reach the peak concentration.
- Evaluate the PK parameter of the time to reach the maximum concentration (Tmax) of PMG1015. [Throughout the study，approximately 2 years.]
Tmax refers to the time when a drug reaches its maximum concentration and exhibits its maximum effect in the body.
- Evaluate the PK parameter of the elimination half-life (t1/2) of PMG1015. [Throughout the study，approximately 2 years.]
t1/2 refers to the time required for the drug concentration in the blood to decrease by half.
- Evaluate the PK parameter of the clearance rate (CL) of PMG1015. [Throughout the study，approximately 2 years.]
CL is the volume of liquid containing a drug that is completely eliminated by the excretory organs per unit time, and its unit is usually mL·(min·kg)-1 or L·(h·kg)-1.
- Evaluate the PK parameter of the distribution volume (Vz) of PMG1015. [Throughout the study，approximately 2 years.]
Vz is a pharmacokinetic parameter that reflects the extent of drug distribution in various tissues in the body.
- Evaluate the PK parameter of the elimination rate constant (λz) of PMG1015. [Throughout the study，approximately 2 years.]
λz refers to the ratio of the amount of compound eliminated per unit time to the total amount, with its unit being the reciprocal of time.
- Relationship between the dose and exposure. [Throughout the study，approximately 2 years.]
Dose refers to the quantity of drug administered at one time that produces a therapeutic effect.
- Incidence of PMG1015-induced and PMG1015-enhanced ADAs. [Throughout the study，approximately 2 years.]
Immunogenicity assessment is mainly based on anti-drug antibodies (ADAs), including the incidence of PMG1015-induced and PMG1015-enhanced ADAs.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- Able to understand the study procedures and method, willing to complete the study as required by the clinical study protocol, and sign the ICF;
-
- Males or females, aged between 40 and 85 years of age, inclusive at signature of ICF.
-
- Body weight ≥ 50 kg for males and ≥40 kg for females;
-
- 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);
-
- Forced vital capacity percent predicted (FVCpp) from 45% to 90%, inclusive at screening;
-
- Diffusing capacity of the lung for carbon monoxide (DLCO; corrected for haemoglobin) from 30% to 90% of the predicted, inclusive at screening;
-
- 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:
-
- 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 with range of emphysema more than that of pulmonary fibrosis as indicated by chest HRCT (conclusion from independent imaging review shall prevail) at screening;
-
- Patients accompanying with obstructive airway diseases (such as FEV1/FVC < 0.7 after bronchodilator therapy);
-
- 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 require ≥ 15 hours of daily oxygen therapy;
-
- 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;
-
- Patients who received corticosteroids (Prednisone Acetate Tablets > 15 mg/day or an equivalent dose of other corticosteroids) within 1 month prior to screening;
-
- 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;
-
- 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 (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;
-
- 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 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);
-
- 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;
-
- 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;
-
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2×Upper Limit of Normal (ULN) or Total Bilirubin ≥1.5×ULN;
-
- Serum creatinine ≥1.5×ULN;
-
- Patients with active hepatitis, syphilis, or positive for HIV antibody;
-
- 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;
-
- 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;
-
- A former smoker who quitted for ≤ 3 months, or unable to quit smoking throughout the study;
-
- A suspected or confirmed alcohol or drug abuser;
-
- 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;
-
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | China-Japan Friendship Hospital | Beijing | Beijing | China | 100029 |
| 2 | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510120 |
| 3 | Tongji Hospital, Tongji Medical College of HUST | Wuhan | Hubei | China | 430030 |
| 4 | Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China | 210008 |
| 5 | Shanghai Chest Hospital | Shanghai | Shanghai | China | 200030 |
| 6 | Shanghai Pulmonary Hospital | Shanghai | Shanghai | China | 200433 |
Sponsors and Collaborators
- Pulmongene Ltd.
Investigators
- Principal Investigator: Chen Wang, PhD, China-Japan Friendship Hospital
- Principal Investigator: Huaping Dai, PhD, China-Japan Friendship Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PMG1015_CHN_Ib