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New drug SV001 aims to slow lung scarring in IPF patients

NCT ID NCT07121413

Disease control Sponsor: Shanghai Synvida Biotechnology Co.,Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, SV001, in 48 adults with idiopathic pulmonary fibrosis (IPF), a disease that causes lung scarring and makes breathing hard. The main goal is to check if SV001 is safe and how the body processes it. Participants will receive either SV001 or a placebo, and researchers will monitor side effects and drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis (IPF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dongfang Hospital Affiliated to Tongji University

    RECRUITING

    Shanghai, China

  • General Hospital of Tianjin Medical University

    RECRUITING

    Tianjin, China

  • Hangzhou First People's Hospital

    RECRUITING

    Hangzhou, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, China

  • Huadong Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, China

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, China

  • Shanghai Pulmonary Hospital

    RECRUITING

    Shanghai, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, China

  • The Affiliated Hospital of Inner Mongolia Medical University

    RECRUITING

    Neimeng, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, China

  • The First Affiliated Hospital of Guangzhou Medical University

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, China

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