Idiopathic Pulmonary Fibrosis(IPF)
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
Interventions
DRUGSV001
SV001 ： Multiple-dose
DRUGPlacebo
Placebo ： Multiple-dose
Sponsors
Shanghai Synvida Biotechnology Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria; 2. Subjects must agree to use highly effective contraception during the study and for 6 months after the last administration of the study drug; 3. 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.
Exclusion criteria
1. Subjects with a history of drug or other allergies, or those judged by the investigator to be potentially allergic to the study drugs; 2. Presence of any other clinically significant pulmonary diseases besides IPF at screening; 3. Any known contraindications to performing pulmonary function tests at screening; 4. Respiratory or systemic infections requiring anti-infective therapy within 1 month prior to randomization; 5. Acute exacerbation of IPF within 4 months prior to randomization; 6. Use of any medication known to cause or worsen pulmonary fibrosis, as assessed by the investigator, within 3 months prior to screening; 7. History of smoking within 3 months prior to screening, or unwillingness to quit smoking throughout the study period; 8. Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period; 9. Presence of specified abnormal laboratory test results at screening; 10. Evidence of renal impairment or end-stage renal disease requiring dialysis at screening; 11. Active hepatitis virus infection; history of acquired or congenital immunodeficiency disease; 12. History of malignancy within 5 years prior to screening; 13. Difficulty with venipuncture or a history of needle phobia or blood phobia; 14. Positive pregnancy tests or currently lactating at screening; 15. Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization; 16. Any other condition that the investigator consider unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Approximately 1 years | Adverse event type, incidence, duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Approximately 1 years | PK (Pharmacokinetics) |
| Peak time（Tmax） | Approximately 1 years | PK (Pharmacokinetics) |
| Area under the plasma concentration versus time curve (AUC) | Approximately 1 years | PK (Pharmacokinetics) |
| half-life（T1/2） | Approximately 1 years | PK (Pharmacokinetics) |
| Immunogenicity | Approximately 1 years | ADA（Anti-drug antibody） |
Countries
China
Contacts
CONTACTJinfu Xu
Outcome results
None listed