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

Korábbi kezelés

• 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;

Más betegség

• 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;

Egyéb

• 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.

• 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.