Evaluating the safety and tolerability of SV001 in healthy Chinese adults

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.

This study is testing a new drug called SV001 in healthy Chinese adults to see if it's safe and how well it works compared to a placebo.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Shanghai Synvida Biotechnology Co.,Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06267183 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety, tolerability, pharmacokinetics, and immunogenicity of the investigational drug SV001 compared to a placebo in healthy adult volunteers from China. Participants will be closely monitored for any adverse reactions and overall health during the trial. The study is designed to gather essential data that will inform future research and potential therapeutic applications for conditions like idiopathic pulmonary fibrosis.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adult volunteers aged 18-65 with a Body Mass Index between 19 and 26 kg/m2.

Not a fit: Patients with a history of respiratory issues or other significant health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a better understanding of SV001's safety profile, paving the way for its use in treating idiopathic pulmonary fibrosis.

How similar studies have performed: While this study focuses on a specific investigational drug, similar studies evaluating safety and tolerability of new treatments have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. 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;
2. 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;
3. Subjects must be in good health as judged by the investigator.
4. Reliable contraception must be assured during and for some time after the trial.

Exclusion Criteria:

1. Subjects with a history of drug or other substance anaphylaxis;
2. Subjects with respiratory symptoms or abnormal respiratory tract;
3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
4. Subjects with other diseases or factors with abnormal clinical manifestations;
5. 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;
6. Subjects who smoked more than 5 cigarettes a day in the period before screening;
7. 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;
8. 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;
9. Subjects who used other drugs within a certain period of time before receiving the investigational drug;
10. Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;
11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.
12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;
13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;
14. 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;
15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;
16. Any other status in which the investigator deems inappropriate to participate in the present study.

Where this trial is running

Shanghai

• Shanghai Xuhui District Central Hospital — Shanghai, China (Recruiting)

Conditions Idiopathic Pulmonary Fibrosis