Actively Recruiting
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
Led by Shanghai Synvida Biotechnology Co.,Ltd. · Updated on 2026-03-11
53
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
CONDITIONS
Official Title
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must fully understand the trial and voluntarily sign informed consent.
- Body Mass Index must be between 19 and 26 kg/m2.
- Males must weigh at least 50 kg; females must weigh at least 45 kg.
- Subjects must be in good health as judged by the investigator.
- Reliable contraception must be used during and after the trial.
You will not qualify if you...
- History of drug or substance anaphylaxis.
- Presence of respiratory symptoms or abnormal respiratory tract.
- Current oral diseases that may affect drug or device use.
- Other diseases or abnormal clinical signs.
- History of drug abuse or positive urine narcotics test.
- Smoking more than 5 cigarettes per day before screening.
- Consuming over 14 alcohol units per week before screening or positive breath alcohol test.
- Recent severe disease or major surgery before receiving the drug.
- Use of other drugs recently before receiving the drug.
- FEV1 or FVC less than or equal to 80% predicted value.
- Positive for HIV, Hepatitis B, Hepatitis C, or Syphilis antibodies.
- Difficulty with blood collection or history of blood phobia.
- Pregnancy or lactation during screening.
- Participation in other drug trials or drug use recently.
- Blood donation or loss over 400 mL recently.
- Any other condition deemed inappropriate 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 District Central Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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