A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

NCT06267183 | Recruiting Early Phase 1

• 1 other identifier: SV001-101
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

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 ： single-dose

SV001

Placebo DRUG

Placebo ： single-dose

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai Synvida Biotechnology Co.,Ltd.: lead

Study Sites (1)

Shanghai Xuhui District Central Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 20, 2024
• Study Start: January 12, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 11, 2026

Record last verified: 2025-04

Locations

CN (1)