About this trial
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Any known contraindications to performing pulmonary function tests at screening;
Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization;
Trial design
Parallel
Treatments tested in this trial
SV001
DrugSV001 : Multiple-dose
Placebo
DrugPlacebo : Multiple-dose
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Secondary outcomes
Peak Plasma Concentration (Cmax)
PK (Pharmacokinetics)
Peak time(Tmax)
PK (Pharmacokinetics)
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
half-life(T1/2)
PK (Pharmacokinetics)
Sponsors and contacts
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