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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorShanghai Synvida Biotechnology Co.,Ltd.

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

Qualifiers

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

Treatments tested in this trial

  • SV001
  • Placebo

Treatment groups

48 Participants
are divided into 2 treatment groups