drugset / Trial / NCT06607380
A Randomized, Open-Label, Parallel-Design Pharmacokinetic and Pharmacodynamic Interaction Study of TNM002 and Adsorbed Tetanus Vaccine
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.
Timeline
- Start
- 2022-08-13
- Primary completion
- 2023-04-10
- Completion
- 2023-04-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adsorbed tetanus vaccine | Vaccine | — | Intramuscular |
| Subject | SILTARTOXATUG | Monoclonal antibody | — | Intramuscular |