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

Official title

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.

Overview

The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.

Interventions

• Drug SV001
  SV001 ： single-dose
• Drug Placebo
  Placebo ： single-dose

Primary outcome measures

• Incidence of Treatment-Emergent Adverse Events [Time frame: Approximately 1 years]

Secondary outcome measures (5)

• Peak Plasma Concentration (Cmax) [Time frame: Approximately 1 years]
• Peak time（Tmax） [Time frame: Approximately 1 years]
• Area under the plasma concentration versus time curve (AUC) [Time frame: Approximately 1 years]
• half-life（T1/2） [Time frame: Approximately 1 years]
• Immunogenicity [Time frame: Approximately 1 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shanghai Xuhui District Central Hospital — Shanghai

Identifiers

NCT: NCT06267183 · SV001-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗