Clinical trials: Efgartigimod
Healthy Volunteers
A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers
This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.
- Trial name
- NCT04564066
- Testing
- efgartigimod IV, efgartigimod PH20 SC
- Where
- Netherlands
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
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…
- Trial name
- NCT04073589
- Testing
- ARGX-113 with rHuPH20
- Where
- Netherlands
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV
This is a randomized, open-label, placebo-controlled phase 1 study in healthy adult volunteers to provide information regarding vaccination with a common pneumococcal polysaccharide vaccine while receiving efgartigimod.
- Trial name
- NCT05163834
- Testing
- Efgartigimod, PNEUMOVAX 23
- Where
- Netherlands
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- argenx
Bioequivalence
A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults
This is a randomized, open-label, parallel-group, single-dose study comparing the pharmacokinetics of efgartigimod in blood following a single administration of efgartigimod PH20 SC via a prefilled syringe versus a vial + syringe…
- Trial name
- NCT05817435
- Testing
- efgartigimod PH20 SC as a prefilled syringe presentation, efgartigimod PH20 SC as a vial + syringe presentation
- Where
- 2 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Renal Impairment
A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod
A study to test how kidney problems influence the blood concentrations of efgartigimod
- Trial name
- NCT05927415
- Testing
- Efgartigimod IV
- Where
- 2 sites in Germany
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- argenx