Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Phase I 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
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SV003 in healthy adult participants aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase I clinical trial aims to understand how SV003 behaves in the body and its safety profile in individuals without active or chronic diseases. The study is sponsored by Shanghai Synvida Biotechnology Co., Ltd. and focuses on healthy volunteers. Participants will receive a single dose of either the study drug SV003 or a placebo. The trial uses a randomized assignment to one of these two groups and includes a double-blind design, meaning neither participants nor researchers know who receives which treatment during the study. The dosing involves a single administration, after which participants will be monitored. During the approximately three-month study period, participants will undergo regular assessments to track any treatment-emergent adverse events. Researchers will also measure pharmacokinetic parameters such as peak plasma concentration, peak time, area under the plasma concentration curve, half-life, and immunogenicity. Participants will be closely monitored for safety and tolerability throughout the study to gather comprehensive data on SV003's effects.
CONDITIONS
Brief 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) between 18.5 and 30 kg/m² for Chinese participants, and between 18.5 and 32 kg/m² for Caucasian participants
- Male participants must weigh at least 50 kg, and female participants at least 45 kg
- Healthy status with no evidence of active or chronic diseases
- Ability to participate in the study, 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 disease within 1 month prior to drug administration or diseases likely to relapse during or after the study
- Abnormal examination or laboratory test results deemed clinically significant by the investigator
- Positive tests for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or Treponema pallidum antibody
- History of drug abuse or positive drug screen within past 2 years
- History of alcohol dependence or positive breath alcohol test within past 2 years
- Smoking 5 or more cigarettes daily within 3 months prior to screening
- Recent blood donation or blood loss exceeding specified amounts
- Allergic constitution or allergy to the study drug, similar drugs, or excipients
- Participation in investigational drug or device studies within past 3 months
- Female participants who are pregnant, breastfeeding, postmenopausal, or have irregular menstrual cycles
- Female participants of childbearing potential or male participants with partners of childbearing potential who refuse reliable contraception during the 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up for approximately 3 months
Participants receive a single dose of SV003 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Multiple visits for assessments over approximately 3 months
Trial Site Locations
Total: 1 location
1
Shanghai Xuhui Central Hospital
Shanghai, China, 200237
Actively Recruiting
Research Team
Q
Qian Chen
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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