Idiopathic Pulmonary Fibrosis(IPF)Phase 2NCT07121413
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SV001 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 study testing SV001 in people with Idiopathic Pulmonary Fibrosis(IPF), run by Shanghai Synvida Biotechnology Co.,Ltd. at 12 sites in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis(IPF)
- What is being tested?
- SV001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 12 sitesChina
- Study dates
- 4 Nov 2025to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu
Lu Guo
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou
Qun Luo
- Recruiting
Hangzhou First People's Hospital
Hangzhou
Limin Wang
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Xuan Wan
- Recruiting
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing
Min Cao
- Recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Neimeng
Junzhen Gao
- Recruiting
Dongfang Hospital Affiliated to Tongji University
Shanghai
Qiang Li
- Recruiting
Huadong Hospital Affiliated to Fudan University
Shanghai
Jinfu Xu, 86-21-62483180, hdyyll@126.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai
Qiuhong Li
- Recruiting
General Hospital of Tianjin Medical University
Tianjin
Jie Cao
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Bi Chen
- Recruiting
Henan Provincial People's Hospital
Zhengzhou
Xiaoju Zhang
About this study
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
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
- Conditions
- Idiopathic Pulmonary Fibrosis(IPF)
- Being tested
- SV001, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SV001Drug
SV001 ： Multiple-dose
PlaceboDrug
Placebo ： Multiple-dose
| Study group | Role | What they receive |
|---|---|---|
| SV001 | Experimental | Not described Receives: Drug: SV001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration
Measured: Approximately 1 years
Secondary outcomes (5)
Peak Plasma Concentration (Cmax)
PK (Pharmacokinetics)
Measured: Approximately 1 years
Peak time（Tmax）
PK (Pharmacokinetics)
Measured: Approximately 1 years
Area under the plasma concentration versus time curve (AUC)
PK (Pharmacokinetics)
Measured: Approximately 1 years
half-life（T1/2）
PK (Pharmacokinetics)
Measured: Approximately 1 years
Immunogenicity
ADA（Anti-drug antibody）
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start4 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis(IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Synvida Biotechnology Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121413
- Sponsor's protocol ID
- SV001-201
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07121413
- Acronym / sponsor ID
- SV001-201
- Conditions
- Idiopathic Pulmonary Fibrosis(IPF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai Synvida Biotechnology Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SV001 | Experimental | Drug: SV001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SV001SV001 ： Multiple-dose | Drug | SV001 |
| PlaceboPlacebo ： Multiple-dose | Drug | Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: Approximately 1 years
Adverse event type, incidence, duration
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Related trials for Idiopathic Pulmonary Fibrosis(IPF)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingPhase 2
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF)
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SV001 in people with Idiopathic Pulmonary Fibrosis(IPF), run by Shanghai Synvida Biotechnology Co.,Ltd. at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinfu Xu (86-21-62483180, hdyyll@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: Approximately 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.