Status:
RECRUITING
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.
Lead Sponsor:
Shanghai Synvida Biotechnology Co.,Ltd.
Conditions:
Healthy Participants
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
Eligibility Criteria
Inclusion Criteria:
- 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;
- Healthy status: No evidence of active or chronic diseases in participants;
- Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.
Exclusion Criteria:
- Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;
- 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;
- Subjects with designated examination results reaching a specified value;
- Subjects with abnormal laboratory test results deemed clinically significant by the investigator;
- Subjects positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody;
- Subjects with a history of drug abuse within the past 2 years, or with a positive urine drug screen on Day -1;
- Subjects with a history of alcohol dependence within the past 2 years, or with a positive breath alcohol test result on Day -1;
- Subjects with an average daily cigarette consumption of ≥ 5 cigarettes within 3 months prior to screening;
- 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;
- Subjects with an allergic constitution, or with a history of allergy to the study drug, drugs of the same class or excipients;
- Subjects who have participated in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration;
- Female subjects with a positive pregnancy test during the screening period or on Day -1, or who are breastfeeding;
- Chinese female subjects who are postmenopausal or have an irregular menstrual cycle;
- 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;
- Any other factors that the investigator deems may render a subject unsuitable for study participation.
Key Trial Info
Start Date :
April 4 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07469085
Start Date
April 4 2026
End Date
March 31 2027
Last Update
April 8 2026
Active Locations (1)
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1
Shanghai Xuhui Central Hospital
Shanghai, China, 200237