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

NCT06939777 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2025-04-25

No results posted yet for this study

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.

Conditions

  • Tetanus

Interventions

BIOLOGICAL

SNA02-48

intramuscular injection

BIOLOGICAL

Placebo

intramuscular injection

BIOLOGICAL

HTIG

intramuscular injection

BIOLOGICAL

Tetanus Toxoid

intramuscular injection

Sponsors & Collaborators

  • Sinovac Life Sciences Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2025-12-31
Completion
2026-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939777 on ClinicalTrials.gov