A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
- Registration Number
- NCT06267183
- Lead Sponsor
- Shanghai Synvida Biotechnology Co.,Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 53
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SV001 SV001 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events Approximately 1 years Adverse event type, incidence, duration
- Secondary Outcome Measures
Name Time Method Peak time（Tmax） Approximately 1 years PK (Pharmacokinetics)
half-life（T1/2） Approximately 1 years PK (Pharmacokinetics)
Peak Plasma Concentration (Cmax) Approximately 1 years PK (Pharmacokinetics)
Area under the plasma concentration versus time curve (AUC) Approximately 1 years PK (Pharmacokinetics)
Immunogenicity Approximately 1 years ADA（Anti-drug antibody）
Trial Locations
- Locations (1)
Shanghai Xuhui District Central Hospital
🇨🇳Shanghai, China