Healthy Participants
Conditions
Brief summary
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
Interventions
DRUGSV003
SV003：Single-dose
DRUGPlacebo
Placebo ： Single-dose
Sponsors
Shanghai Synvida Biotechnology Co.,Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg; 2. Healthy status: No evidence of active or chronic diseases in participants; 3. Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.
Exclusion criteria
1. Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases; 2. Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study; 3. Subjects with designated examination results reaching a specified value; 4. Subjects with abnormal laboratory test results deemed clinically significant by the investigator; 5. Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody; 6. Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1; 7. Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1; 8. Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening; 9. Subjects who have donated blood or lost blood ≥ 400 mL within 3 months prior to drug administration, or donated blood or lost blood ≥ 200 mL within 1 month, or with a history of blood product use; 10. Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients; 11. Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration; 12. Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding; 13. Chinese female subjects who are postmenopausal or have an irregular menstrual cycle; 14. Female subjects of childbearing potential, or male subjects whose female partners are of childbearing potential, who refuse to adopt reliable contraceptive measures during the study and for 6 months after the last drug administration; 15. Any other factors that the investigator deems may render a subject unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Approximately 3 months | Adverse event type, incidence, duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Approximately 3 months | PK (Pharmacokinetics) |
| Peak time（Tmax） | Approximately 3 months | PK (Pharmacokinetics) |
| Area under the plasma concentration versus time curve (AUC) | Approximately 3 months | PK (Pharmacokinetics) |
| half-life（T1/2） | Approximately 3 months | PK (Pharmacokinetics) |
| Immunogenicity | Approximately 3 months | ADA（Anti-drug antibody） |
Countries
China
Contacts
CONTACTQian Chen
Outcome results
None listed