Status:
RECRUITING
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
Lead Sponsor:
Shanghai Synvida Biotechnology Co.,Ltd.
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
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.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Any other status in which the investigator deems inappropriate to participate in the present study.
Key Trial Info
Start Date :
January 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06267183
Start Date
January 12 2024
End Date
December 30 2026
Last Update
March 11 2026
Active Locations (1)
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1
Shanghai Xuhui District Central Hospital
Shanghai, China