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TetanusPhase 1/2NCT06939777

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SNA02-48 Injection in Chinese Adult Participants

A Phase 1/2 study testing SNA02-48, HTIG and Tetanus Toxoid in people with Tetanus, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Tetanus
What is being tested?
SNA02-48, HTIG and Tetanus Toxoid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
255 participants
Where
1 siteChina
Study dates
28 Apr 2025to 30 Mar 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Participants who have smoked≥5 cigarettes per day within 3 months prior to screening;
  • Participants who have consumed >14 alcohol units per week within 3 months prior to screening (1 alcohol unit = 14 grams of pure alcohol = 360 ml beer, 150 ml wine, or 45 ml distilled spirits/liquor);
  • Acute diseases, acute exacerbation of chronic diseases or surgical history within 4 weeks prior to screening;
  • Receipt of live attenuated vaccines within 4 weeks prior to screening or subunit/inactivated vaccines (or other vaccine types) within 7 days prior to screening;
  • Receipt of any prescription medications, over-the-counter (OTC) medications supplements, or functional vitamins within 14 days prior to screening;
  • Participants who have consumed special diets (e.g., grapefruit, etc.) or engaged in strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, or excretion within 14 days prior to screening;
  • Women in pregnancy or lactation or those with a positive pregnancy test;
  • Participants who have consumed any caffeine-containing or tea within 24 hours prior to investigational drug administration;
  • Ear temperature during the screening or baseline period is> 37.6℃;
  • Skin lesions (including inflammation, ulcers, rashes, or scars) at the target injection site that may interfere with drug administration or observation of local reactions;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Hospital of Anhui Medical Universiy

    Hefei, Anhui, 230601

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

This is a randomized, double-blind, placebo/active-controlled phase I/II study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SNA02-48 Injection in Chinese adult participants.

In the phase I portion of the study, 30 adult participants will be sequentially enrolled into three cohorts. Each participant will receive a single intramuscular (IM) dose of either SNA02-48 or placebo, depending on the cohort to which they are assigned. The phase I part will last for 105 days following the assessments of safety, PK, PD and ADA.

In the phase II portion of the study, 225 adult participants will be enrolled and randomly assigned to nine groups.The phase II part will last for 105 days following the assessments of safety, PK, PD and ADA.

Conditions
Tetanus
Being tested
SNA02-48, Placebo, HTIG, Tetanus Toxoid
Medical subject headings
Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SNA02-48Biological

    intramuscular injection

  • PlaceboBiological

    intramuscular injection

  • HTIGBiological

    intramuscular injection

  • Tetanus ToxoidBiological

    intramuscular injection

Study groups in NCT06939777
Study groupRoleWhat they receive
Cohort 1:low-dose SNA02-48/placebo (Phase I)ExperimentalParticipants will be randomly assigned to receive either low-dose SNA02-48 or placebo.
Receives: Biological: SNA02-48; Biological: Placebo
Cohort 2: medium-dose SNA02-48/placebo (Phase I)ExperimentalParticipants will be randomly assigned to receive either medium-dose SNA02-48 or placebo.
Receives: Biological: SNA02-48; Biological: Placebo
Cohort 3: high-dose SNA02-48/placebo (Phase I)ExperimentalParticipants will be randomly assigned to receive either high-dose SNA02-48 or placebo.
Receives: Biological: SNA02-48; Biological: 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
Receives: Biological: SNA02-48; Biological: 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
Receives: Biological: SNA02-48; Biological: 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
Receives: Biological: SNA02-48; Biological: 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）
Receives: Biological: SNA02-48; Biological: Tetanus Toxoid
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）
Receives: Biological: SNA02-48; Biological: Tetanus Toxoid
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）
Receives: Biological: SNA02-48; Biological: Tetanus Toxoid
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）
Receives: Biological: Placebo; Biological: Tetanus Toxoid
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
Receives: Biological: Placebo; Biological: HTIG
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）
Receives: Biological: HTIG; Biological: Tetanus Toxoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse reactions

    Measured: Up to 105 days

  2. The increase in serum tetanus antibody levels from baseline at 12 hours post-administration

    Measured: 12 hours after administration

Secondary outcomes (12)

  1. Time of maximum plasma concentration (Tmax)

    Measured: Up to 105 days

  2. Peak plasma concentration(Cmax)

    Measured: Up to 105 days

  3. Terminal half-life (T1/2)

    Measured: Up to 105 days

  4. clearance(CL)

    Measured: Up to 105 days

  5. Apparent Volume of Distribution(Vd)

    Measured: Up to 105 days

  6. Area under the plasma concentration time curve (AUC)

    Measured: Up to 105 days

  7. Terminal Elimination Rate Constant(λz)

    Measured: Up to 105 days

  8. Mean Residence Time (MRT)

    Measured: Up to 105 days

  9. Serum tetanus antibody level

    Measured: Up to 105 days

  10. Positive rate of serum tetanus antibody

    Measured: Up to 105 days

  11. The increase in serum tetanus antibody levels from baseline after administration

    Measured: Up to 105 days

  12. Incidence of anti-drug antibody (ADA) and neutralizing antibody (Nab)

    Measured: Up to 105 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start28 Apr 2025
  3. Primary completion8 Dec 2025
  4. Study completion30 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06939777
Sponsor's protocol ID
PRO-SNA02-48-1001
Status last verified
Jun 2026
First submitted
15 Apr 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SNA02-48, HTIG and Tetanus Toxoid in people with Tetanus, run by Sinovac Life Sciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse reactions (time frame: Up to 105 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06939777.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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