Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adul… (NCT06939777) | Clinical Trial Compass
CompletedPhase 1/2
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants
China255 participantsStarted 2025-04-28
Plain-language summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the full human anti-tetanus toxin monoclonal antibody SNA02-48 injection and compare the Tetanus-antibody levels and safety of SNA02-48 with human tetanus immunoglobulin (HTIG) in Chinese adult participants.
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18-59 years of age；
. Participants have the ability to understand and agree to sign the informed consent form；
. Male participants with a weight of≥50.0kg; Female participants with a weight of ≥ 45.0kg and the weight of both men and women≤90 kg, 18.5 kg/m2≤BMI \< 24.0 kg/m2;
. Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures from the date of signing the informed consent form until 6 months after the administration of the investigational drug, and have no plans to donate sperm or ova during this period.
Exclusion criteria
. Previous history of tetanus infection;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse reactions
Timeframe: Up to 105 days
2
The increase in serum tetanus antibody levels from baseline at 12 hours post-administration
. Has received tetanus vaccines or vaccines containing tetanus toxoid antigen (DTP, DT, meningococcal conjugate vaccine, etc.) within the last 10 years, or has received a tetanus immunoglobulin or tetanus antitoxin within the previous 6 months;
. Participants with positive tetanus antibody IgG test results during the screening period；
. Participants who are known to be allergic to experimental drugs (including excipients, HTIG, and other therapeutic monoclonal antibodies), or who suffer from severe allergic diseases, may damage the safety of the participants by the judgment of the investigator;
. Positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), HIV antibody (HIV Ab), or Treponema pallidum antibody (TP Ab);
. Physical examinations, vital signs, electrocardiograms (ECGs), laboratory tests, or other test results during the screening or baseline period that are judged by the investigator to be abnormal and clinically significant;
. Participants with uncontrolled chronic or severe disease history, including but not limited to cardiovascular disease, hematological system disease, hepatobiliary or renal diseases, gastrointestinal diseases, respiratory disease, malignant tumor, history of major organ transplantation, which may affect the pharmacokinetic profiles or safety evaluation of the investigational drug as determined by the investigator;
. Autoimmune diseases or immunodeficiency disorders (including but not limited to systemic lupus erythematosus (SLE), ankylosing spondylitis (AS), autoimmune thyroid diseases (AITD), asplenia, functional asplenia, or human immunodeficiency virus infection (HIV));