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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06267183
Other study ID # SV001-101
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 12, 2024
Est. completion date March 30, 2025

Study information

Verified date February 2024
Source Shanghai Synvida Biotechnology Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 53
Est. completion date March 30, 2025
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. 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; 2. 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; 3. Subjects must be in good health as judged by the investigator. 4. Reliable contraception must be assured during and for some time after the trial. Exclusion Criteria: 1. Subjects with a history of drug or other substance anaphylaxis; 2. Subjects with respiratory symptoms or abnormal respiratory tract; 3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices; 4. Subjects with other diseases or factors with abnormal clinical manifestations; 5. 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; 6. Subjects who smoked more than 5 cigarettes a day in the period before screening; 7. 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; 8. 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; 9. Subjects who used other drugs within a certain period of time before receiving the investigational drug; 10. Screening period: FEV1=80% predicted value or FVC=80% predicted value; 11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum. 12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia; 13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period; 14. 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; 15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening; 16. Any other status in which the investigator deems inappropriate to participate in the present study.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China Shanghai Xuhui District Central Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Synvida Biotechnology Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-Emergent Adverse Events Adverse event type, incidence, duration Approximately 1 years
Secondary Peak Plasma Concentration (Cmax) PK (Pharmacokinetics) Approximately 1 years
Secondary Peak time(Tmax) PK (Pharmacokinetics) Approximately 1 years
Secondary Area under the plasma concentration versus time curve (AUC) PK (Pharmacokinetics) Approximately 1 years
Secondary half-life(T1/2) PK (Pharmacokinetics) Approximately 1 years
Secondary Immunogenicity ADA(Anti-drug antibody) Approximately 1 years
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