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A Phase I, Single-center, Randomized, Double-blind, Single-dose, Dose-ascending, Placebo-controlled 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and immune response of a drug called SV001 compared to a placebo in healthy adult volunteers from China. This early phase 1, randomized, double-blind, and placebo-controlled study aims to understand how SV001 behaves in the body and whether it causes any adverse effects. The study focuses on adults aged 18 to 45 years who are in good health. Participants will receive a single dose of either SV001 or a placebo. The study uses a dose-escalation design, meaning doses may increase to assess safety. The trial is conducted at a single center and uses a quadruple-blind method where participants, care providers, investigators, and outcome assessors are unaware of which treatment is given. The intervention period includes administration of the study drug followed by monitoring. During the study, participants will undergo various assessments including monitoring for any treatment-emergent adverse events, measuring drug levels in the blood over time, and checking for immune responses to SV001. These evaluations will take place over approximately one year. Researchers will also monitor participants' overall health, respiratory function, and conduct laboratory tests to ensure safety throughout the trial.
CONDITIONS
Brief 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 volunteer by signing the Informed Consent Form
- Body Mass Index between 19 and 26 kg/m2, with males weighing at least 50 kg and females 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 other substance anaphylaxis
- Respiratory symptoms or abnormal respiratory tract
- Current oral disease that may affect use of trial drug or devices
- Other diseases with abnormal clinical manifestations
- History of drug abuse or positive urine narcotics test
- Smoking more than 5 cigarettes a day before screening
- Consuming more than 14 units of alcohol per week or positive breath alcohol test
- Recent severe disease or major surgery or expected major surgery during trial
- Use of other drugs within a certain period before investigational drug
- FEV1 or FVC less than or equal to 80% predicted value at screening
- Positive antibody tests for HIV, Hepatitis B, Hepatitis C, or Treponema Pallidum
- Difficulty in venous blood collection or history of blood phobia
- Female subjects pregnant or lactating during screening or baseline
- Participation in other drug trials or drug use within a certain period before investigational drug
- History of blood donation or blood loss over 400 mL before screening
- Any other condition deemed inappropriate 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.
Duration - Single dosing with approximately 1 year of follow-up monitoring
Participants receive a single dose of SV001 or placebo to evaluate safety, tolerability, and pharmacokinetics.
1 baseline visit and multiple follow-up visits over approximately 1 year
Trial Site Locations
Total: 1 location
1
Shanghai Xuhui District Central Hospital
Shanghai, China
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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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