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Tests treatment safety and results for Idiopathic Pulmonary Fibrosis(IPF)
Official title A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07121413
What this study is testing
What is SV001?
SV001 is an investigational medicine, being studied as a potential treatment for idiopathic pulmonary fibrosis(ipf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- people with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;
- people 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...
You likely can't join if
- people 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;
- 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;
See the full eligibility criteria
- people with a confirmed diagnosis of IPF and pulmonary function meeting the protocol-specified criteria;
- people 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.
- people 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;
- 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;
- Presence of clinically significant cardiovascular, cerebrovascular, hematological, neurological, psychiatric, or metabolic disease at screening, or plans for major surgery during the study period;
- Presence of specified abnormal laboratory test results at screening;
- 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;
- Positive pregnancy tests or currently lactating at screening;
- Participation in another clinical trial and receipt of other investigational drugs within 3 months prior to randomization;
- Any other condition that the investigator consider unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, China
- Guangzhou, China
- Hangzhou, China
- Nanchang, China
- Nanjing, China
- Neimeng, China
- Shanghai, China
- Tianjin, China
- Xuzhou, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, China; Guangzhou, China; Hangzhou, China; Nanchang, China; Nanjing, China; Neimeng, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.