A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

Korábbi kezelés

• Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;
• Acute exacerbation of IPF within 4 months prior to randomization;
• Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening;
• History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period;
• Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;

Más betegség

• Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs;
• Presence of any other clinically significant pulmonary diseases besides IPF at screening;
• Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;
• Evidence of renal impairment or end-stage renal disease requiring dialysis at screening;
• Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease;
• History of malignancy within 5 years prior to screening;
• Difficulty with venipuncture or a history of needle phobia or blood phobia;
• Any other condition that the investigator consider unsuitable for participation in the study.

Laborértékek

• Presence of specified abnormal laboratory test results at screening;

Egyéb

• Any known contraindications to performing pulmonary function tests at screening;
• Positive pregnancy tests or currently lactating at screening;

• Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;
• Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug;
• Subjucts must be able to understand the study, voluntarily provide written informed consent, and be willing and able to comply with all study-related procedures.