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Recruiting NCT07121413

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

Phase II Interventional Idiopathic Pulmonary Fibrosis(IPF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SV001, Placebo.
Who it may be relevant to
Registry conditions: Idiopathic Pulmonary Fibrosis(IPF). Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase IIa, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis

Overview

The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.

Interventions

  • Drug SV001
    SV001 ： Multiple-dose
  • Drug Placebo
    Placebo ： Multiple-dose

Primary outcome measures

  • Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 1 years]
Secondary outcome measures (5)
  • Peak Plasma Concentration (Cmax) [Time frame: Approximately 1 years]
  • Peak time（Tmax） [Time frame: Approximately 1 years]
  • Area under the plasma concentration versus time curve (AUC) [Time frame: Approximately 1 years]
  • half-life（T1/2） [Time frame: Approximately 1 years]
  • Immunogenicity [Time frame: Approximately 1 years]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 12 centers
  • Sichuan Provincial People's Hospital — Chengdu
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
  • Hangzhou First People's Hospital — Hangzhou
  • The First Affiliated Hospital of Nanchang University — Nanchang
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School — Nanjing
  • The Affiliated Hospital of Inner Mongolia Medical University — Neimeng
  • Dongfang Hospital Affiliated to Tongji University — Shanghai
  • Huadong Hospital Affiliated to Fudan University — Shanghai
  • … and 4 more centers

Identifiers

NCT: NCT07121413 · SV001-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗