CClinicalTrials.gg
RecruitingNCT07121413Updated Feb 11, 2026

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

A Phase 2 interventional study of SV001 and Placebo in Idiopathic Pulmonary Fibrosis(IPF), sponsored by Shanghai Synvida Biotechnology Co.,Ltd.. Recruiting at 12 sites in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Shanghai Synvida Biotechnology Co.,Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis(IPF)
03

In context

Idiopathic Pulmonary Fibrosis

551 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.

This study's planned enrollment of 48 is below the median of 54 across 376 interventional studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Shanghai Synvida Biotechnology Co.,Ltd. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    SV001

    Drug: SV001

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSV001

    SV001 : Multiple-dose

  • DrugPlacebo

    Placebo : Multiple-dose

06

What researchers measure

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Adverse event type, incidence, duration

    Time frame: Approximately 1 years

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    PK (Pharmacokinetics)

    Time frame: Approximately 1 years

  2. Peak time(Tmax)

    PK (Pharmacokinetics)

    Time frame: Approximately 1 years

  3. Area under the plasma concentration versus time curve (AUC)

    PK (Pharmacokinetics)

    Time frame: Approximately 1 years

  4. half-life(T1/2)

    PK (Pharmacokinetics)

    Time frame: Approximately 1 years

  5. Immunogenicity

    ADA(Anti-drug antibody)

    Time frame: Approximately 1 years

07

Study locations

12 of 12 sites recruiting
  • Sichuan Provincial People's Hospital
    Chengdu, China
    • Lu Guo · Contact
    Recruiting
  • The First Affiliated Hospital of Guangzhou Medical University
    Guangzhou, China
    • Qun Luo · Contact
    Recruiting
  • Hangzhou First People's Hospital
    Hangzhou, China
    • Limin Wang · Contact
    Recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
    • Xuan Wan · Contact
    Recruiting
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
    Nanjing, China
    • Min Cao · Contact
    Recruiting
  • The Affiliated Hospital of Inner Mongolia Medical University
    Neimeng, China
    • Junzhen Gao · Contact
    Recruiting
  • Dongfang Hospital Affiliated to Tongji University
    Shanghai, China
    • Qiang Li · Contact
    Recruiting
  • Huadong Hospital Affiliated to Fudan University
    Shanghai, China
    Recruiting
  • Shanghai Pulmonary Hospital
    Shanghai, China
    • Qiuhong Li · Contact
    Recruiting
  • General Hospital of Tianjin Medical University
    Tianjin, China
    • Jie Cao · Contact
    Recruiting
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, China
    • Bi Chen · Contact
    Recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, China
    • Xiaoju Zhang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07121413
Lead sponsor
Shanghai Synvida Biotechnology Co.,Ltd.
Responsible party
Sponsor
First posted
Aug 13, 2025
Start date
Nov 4, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 11, 2026

Study contacts

Jinfu Xu
Contact
hdyyll@126.com
86-21-62483180

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion