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NOT YET RECRUITING
NCT06939777
PHASE1/PHASE2

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

Sponsor: Sinovac Life Sciences Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

255

Start Date

2025-04

Completion Date

2026-02

Last Updated

2025-04-25

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

SNA02-48

intramuscular injection

BIOLOGICAL

Placebo

intramuscular injection

BIOLOGICAL

HTIG

intramuscular injection

BIOLOGICAL

Tetanus Toxoid

intramuscular injection

Locations (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China