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

NCT07121413 | Recruiting Phase 2

• 1 other identifier: SV001-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 12

Brief Summary

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)

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Adverse event type, incidence, duration

  Approximately 1 years

Secondary Outcomes (5)

• Peak Plasma Concentration (Cmax)

  Approximately 1 years

• Peak time（Tmax）

  Approximately 1 years

• Area under the plasma concentration versus time curve (AUC)

  Approximately 1 years

• half-life（T1/2）

  Approximately 1 years

• Immunogenicity

  Approximately 1 years

Study Arms (2)

SV001

EXPERIMENTAL

Drug: SV001

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SV001 DRUG

SV001 ： Multiple-dose

SV001

Placebo DRUG

Placebo ： Multiple-dose

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Synvida Biotechnology Co.,Ltd.: lead

Study Sites (12)

Sichuan Provincial People's Hospital

Chengdu, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, China

RECRUITING

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

Nanjing, China

RECRUITING

The Affiliated Hospital of Inner Mongolia Medical University

Neimeng, China

RECRUITING

Dongfang Hospital Affiliated to Tongji University

Shanghai, China

RECRUITING

Huadong Hospital Affiliated to Fudan University

Shanghai, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

General Hospital of Tianjin Medical University

Tianjin, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jinfu Xu

CONTACT

86-21-62483180; hdyyll@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-08

Locations

CN (12)