Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants
A Randomized, Double-Blind, Controlled, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants
1 other identifier
interventional
255
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedApril 25, 2025
April 1, 2025
8 months
April 15, 2025
April 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of adverse reactions
Up to 105 days
The increase in serum tetanus antibody levels from baseline at 12 hours post-administration
12 hours after administration
Secondary Outcomes (12)
Time of maximum plasma concentration (Tmax)
Up to 105 days
Peak plasma concentration(Cmax)
Up to 105 days
Terminal half-life (T1/2)
Up to 105 days
clearance(CL)
Up to 105 days
Apparent Volume of Distribution(Vd)
Up to 105 days
- +7 more secondary outcomes
Study Arms (12)
Cohort 1:low-dose SNA02-48/placebo (Phase I)
EXPERIMENTALParticipants will be randomly assigned to receive either low-dose SNA02-48 or placebo.
Cohort 2: medium-dose SNA02-48/placebo (Phase I)
EXPERIMENTALParticipants will be randomly assigned to receive either medium-dose SNA02-48 or placebo.
Cohort 3: high-dose SNA02-48/placebo (Phase I)
EXPERIMENTALParticipants will be randomly assigned to receive either high-dose SNA02-48 or placebo.
Group A :low-dose SNA02-48 + placebo (Phase II)
EXPERIMENTALParticipants will receive a single intramuscular (IM) gluteal injection of low-dose SNA02-48 and a single IM deltoid injection of placebo
Group B : medium-dose SNA02-48 + placebo (Phase II)
EXPERIMENTALParticipants will receive a single IM gluteal injection of medium-dose SNA02-48 and a single IM deltoid injection of placebo
Group C : high-dose SNA02-48 + placebo (Phase II)
EXPERIMENTALParticipants will receive a single IM gluteal injection of high-dose SNA02-48 and a single IM deltoid injection of placebo
Group D : low-dose SNA02-48 + Tetanus Toxoid (Phase II)
EXPERIMENTALParticipants will receive a single IM gluteal injection of low-dose SNA02-48 and a single IM deltoid injection of Tetanus Toxoid（TT）
Group E : medium-dose SNA02-48 + Tetanus Toxoid (Phase II)
EXPERIMENTALParticipants will receive a single IM gluteal injection of medium-dose SNA02-48 and a single IM deltoid injection of Tetanus Toxoid（TT）
Group F : high-dose SNA02-48 + Tetanus Toxoid (Phase II)
EXPERIMENTALParticipants will receive a single IM gluteal injection of high-dose SNA02-48 and a single IM deltoid injection of Tetanus Toxoid（TT）
Group G : placebo + Tetanus Toxoid (Phase II)
PLACEBO COMPARATORParticipants will receive a single IM gluteal injection of placebo and a single IM deltoid injection of Tetanus Toxoid（TT）
Group H : Human tetanus immunoglobulin(HTIG) + placebo (Phase II)
ACTIVE COMPARATORParticipants will receive a single IM gluteal injection of Human tetanus immunoglobulin(HTIG) and a single IM deltoid injection of placebo
Group I : Human tetanus immunoglobulin(HTIG) + Tetanus Toxoid（TT） (Phase II)
ACTIVE COMPARATORParticipants will receive a single IM gluteal injection of Human tetanus immunoglobulin(HTIG) and a single IM deltoid injection of Tetanus Toxoid（TT）
Interventions
intramuscular injection
intramuscular injection
intramuscular injection
intramuscular injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous history of tetanus infection;
- 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));
- Participants with coagulation dysfunction that is abnormal and clinically significant as determined by the investigator (e.g., coagulation factor deficiency, platelet abnormalities);
- Current or past history of severe neurological disorders (including but not limited to epilepsy, convulsions, or seizures) or psychiatric disorders, or a family history of psychiatric disorders;
- Have a history of drug abuse or dependence or recreational drug use within 2 years prior to screening, or have a positive urine drug abuse screening before enrollment;
- Participants who have received immunosuppressants or other immunomodulatory therapies (e.g., prednisone≥20 mg/day or equivalent) for≥14 days within the 6 months, cytotoxic therapy, or plan to receive such treatments during the trial period;
- Participants who have received immune globulin or other blood products within the 6 months, or plan to receive such treatments during the trial period;
- Participants who have donated \>400 ml of blood or experienced significant blood loss \>400 ml within 3 months prior to drug administration, or donated plasma or platelets within 1 month prior to drug administration;
- Participants who have participated in other drug or medical device clinical trials within 3 months prior to screening, or plan to participate in other clinical trials during the trial period;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2025
First Posted
April 23, 2025
Study Start
April 1, 2025
Primary Completion
December 1, 2025
Study Completion
February 1, 2026
Last Updated
April 25, 2025
Record last verified: 2025-04