Phase
Condition
Idiopathic Pulmonary Fibrosis
Cystic Fibrosis
Scar Tissue
Treatment
REGEND001
Placebo
Clinical Study ID
Ages 40-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, aged between 40 to 75;
Subjects diagnosed with IPF according to guidelines for the diagnosis of idiopathicpulmonary fibrosis 2022 edition;
Subjects with DLCO (measured/predicted value) ≥30% and <80%, and FVC (measured/predicted value) ≥50% within 3 months prior to screening
Subjects tolerant to bronchofiberscope;
Subjects tolerant to test of lung function;
Subjects able to voluntarily sign the informed consent and cooperate with thecompletion of pulmonary function tests;
Exclusion
Exclusion Criteria:
Female subject who is pregnant, nursing, or planning to be pregnant in half a yearafter using this product (or male subjects planning to have a pregnant spouse);
At the time of screening, subject who is positive in each of treponema pallidumantibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surfaceantigen (HBsAg), hepatitis C virus (HCV) antibody test, except the following: (1)Hepatitis B virus carriers (only HBsAg positive, no hepatitis symptoms and signs,all liver function tests are normal); (2) Cured hepatitis C patients with negativeresult in HCV ribonucleic acid (RNA) test.
Subject with malignant tumors or a history of malignant tumors;
Subject with severe anemia, poorly controlled agranulocytosis and thrombocytopeniaat screening;
Subject at risk of suicide or has a history of mental illness or epilepsy at thetime of screening;
Subject with severe arrhythmias or atrioventricular block of degree II or above,shown by 12-lead Electrocardiogram (ECG);
Subject who participated in other interventional clinical trials in the past 3months;
Subject assessed as inappropriate to participate in this clinical trial byinvestigators.
Study Design
Connect with a study center
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing
ChinaSite Not Available
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian 361021
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai 200127
ChinaSite Not Available
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, Shanghai 200025
ChinaSite Not Available
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