drugset / Trial / NCT04073589
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
RandomizedParallel-groupOpen-labelOther
Summary
The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20 by the subcutaneous (SC) route of administration in healthy adult male subjects.
Timeline
- Start
- 2019-07-17
- Primary completion
- 2019-09-26
- Completion
- 2019-09-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Efgartigimod Alfa | Protein / enzyme biologic | — | Subcutaneous |
| Background | rHuPH20 | Protein / enzyme biologic | — | Subcutaneous |
Indications
No indication recorded.