The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Sichuan Provincial People's Hospital
Chengdu, China
RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Time frame: Approximately 1 years
Peak Plasma Concentration (Cmax)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Peak time(Tmax)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
half-life(T1/2)
PK (Pharmacokinetics)
Time frame: Approximately 1 years
Immunogenicity
ADA(Anti-drug antibody)
Time frame: Approximately 1 years
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Hangzhou First People's Hospital
Hangzhou, China
RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, China
RECRUITINGNanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
RECRUITINGThe Affiliated Hospital of Inner Mongolia Medical University
Neimeng, China
RECRUITINGDongfang Hospital Affiliated to Tongji University
Shanghai, China
RECRUITINGHuadong Hospital Affiliated to Fudan University
Shanghai, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, China
RECRUITINGGeneral Hospital of Tianjin Medical University
Tianjin, China
RECRUITING...and 2 more locations