Idiopathic Pulmonary FibrosisEarly Phase 1NCT06267183
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
A Early Phase 1 study testing SV001 in people with Idiopathic Pulmonary Fibrosis, run by Shanghai Synvida Biotechnology Co.,Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- SV001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2024to 30 Dec 2026
- Phase
- Early Phase 1
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
- Subjects must have a Body Mass Index in the range of 19~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
- Subjects must be in good health as judged by the investigator.
- Reliable contraception must be assured during and for some time after the trial.
Who cannot join
- Subjects with a history of drug or other substance anaphylaxis;
- Subjects with respiratory symptoms or abnormal respiratory tract;
- Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
- Subjects with other diseases or factors with abnormal clinical manifestations;
- Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;
- Subjects who smoked more than 5 cigarettes a day in the period before screening;
Show all 16Show fewer
- Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;
- Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;
- Subjects who used other drugs within a certain period of time before receiving the investigational drug;
- Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;
- Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.
- Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;
- Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;
- Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;
- Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;
- Any other status in which the investigator deems inappropriate to participate in the present study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Xuhui District Central Hospital
Shanghai
Qian Chen, 0086-021-54036058, qchen@shxh-centerlab.com
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
- Conditions
- Idiopathic Pulmonary Fibrosis
- 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 ： single-dose
PlaceboDrug
Placebo ： single-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 posted20 Feb 2024
- Study start12 Jan 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 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 FibrosisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 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
- NCT06267183
- Sponsor's protocol ID
- SV001-101
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2024
- Last updated
- 14 Aug 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 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
- ClinicalTrials.gov ID
- NCT06267183
- Acronym / sponsor ID
- SV001-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Shanghai Synvida Biotechnology Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Feb 2024 (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 safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SV001 | Experimental | Drug: SV001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
- Subjects must have a Body Mass Index in the range of 19~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
- Subjects must be in good health as judged by the investigator.
- Reliable contraception must be assured during and for some time after the trial.
Key exclusion criteria (16 listed)
- Subjects with a history of drug or other substance anaphylaxis;
- Subjects with respiratory symptoms or abnormal respiratory tract;
- Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
- Subjects with other diseases or factors with abnormal clinical manifestations;
- Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;
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 ： single-dose | Drug | SV001 |
| PlaceboPlacebo ： single-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 14 Aug 2026.
Related trials for Idiopathic Pulmonary Fibrosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SV001 in people with Idiopathic Pulmonary Fibrosis, run by Shanghai Synvida Biotechnology Co.,Ltd. at 1 site 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 4 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 14 Aug 2026.