drugset / Trial / NCT04532125
SAD and MAD Study With IV and SC Doses of ARGX-117
RandomizedSequentialQuadruple-blindOther
Summary
This is a phase 1, first-in-human, double-blinded, randomized, placebo-controlled, escalating single and multiple dose levels trial to evaluate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of ARGX-117 administered IV and/or SC. Up to 112 healthy, adult male and female subjects of non-childbearing potential will be enrolled in this trial.
Timeline
- Start
- 2020-08-03
- Primary completion
- 2022-08-26
- Completion
- 2022-08-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empasiprubart | Monoclonal antibody | — | Intravenous |
| Background | rHuPH20 | Protein / enzyme biologic | — | — |
Indications
No indication recorded.