Actively Recruiting
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.
Led by Shanghai Synvida Biotechnology Co.,Ltd. · Updated on 2026-04-08
60
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
CONDITIONS
Official Title
A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body Mass Index (BMI): 18.5 to 30 kg/m8 for Chinese participants, 18.5 to 32 kg/m8 for Caucasian participants
- Male participants must weigh at least 50 kg; female participants must weigh at least 45 kg
- Healthy status with no active or chronic diseases
- Ability to participate, willingness to provide written informed consent, and compliance with study requirements
You will not qualify if you...
- History of chronic diseases or clinically significant systemic diseases
- Serious illness within 1 month prior to drug administration or diseases that may relapse during or after the study
- Abnormal examination results reaching specified values
- Clinically significant abnormal laboratory test results
- Positive for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody
- History of drug abuse within past 2 years or positive urine drug test on Day -1
- History of alcohol dependence within past 2 years or positive breath alcohol test on Day -1
- Smoking 5 or more cigarettes per day within 3 months prior to screening
- Donated or lost blood 400 mL or more within 3 months or 200 mL or more within 1 month prior to drug administration
- Allergic constitution or history of allergy to the study drug, similar drugs, or excipients
- Participation in clinical studies of investigational drugs or medical devices within 3 months prior to drug administration
- Female with positive pregnancy test during screening or Day -1, or breastfeeding
- Chinese female who is postmenopausal or has irregular menstrual cycle
- Female participants of childbearing potential or male participants whose partners are of childbearing potential who refuse reliable contraception during study and for 6 months after last drug administration
- Any other factors deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Xuhui Central Hospital
Shanghai, China, 200237
Actively Recruiting
Research Team
Q
Qian Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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