Tests new drug SV001 for safety in healthy Chinese adult volunteers
Tests SV001 against placebo in healthy Chinese adults aged 18 to 45.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06267183, who can take part
Where in China
- Shanghai Xuhui District Central HospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Synvida Biotechnology Co.,Ltd.
- Trial code
- NCT06267183
- Record updated
- 14 August 2026
- Original description
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.Read full original descriptionShow less
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.
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
Inclusion: 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: 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 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; 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; Subjects with a history of drug or other substance anaphylaxis; 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 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; Subjects with respiratory symptoms or abnormal respiratory tract; Subjects who smoked more than 5 cigarettes a day in the period before screening; Screening period: FEV1≤80% predicted value or FVC≤80% predicted value; Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period; Any other status in which the investigator deems inappropriate to participate in the present study.