NCT06939777

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Sinovac Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
BIOLOGICAL	SNA02-48	intramuscular injection
BIOLOGICAL	Placebo	intramuscular injection
BIOLOGICAL	HTIG	intramuscular injection
BIOLOGICAL	Tetanus Toxoid	intramuscular injection

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2025-04-23
• Last updated: 2025-04-25

Locations

1 site across 1 country: China