Clinical trials: sponsored by 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
Healthy Volunteers (HV), Healthy Volunteer
A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body.
- Trial name
- NCT07673601
- Testing
- Adimanebart IV, Adimanebart SC - formulation A, Adimanebart SC - formulation B
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants
This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe.
- Trial name
- NCT07612020
- Testing
- empasiprubart SC AI, empasiprubart IV
- Where
- Canada
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body.
- Trial name
- NCT06968338
- Testing
- ARGX-213
- Where
- Canada
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
This study aims to assess the safety of ARGX-124 in healthy adults. Another aim is to measure the amount of ARGX-124 in the blood over time to learn how it acts and moves in the body and how the immune system responds to it.
- Trial name
- NCT07377396
- Testing
- ARGX-124
- Where
- Canada
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteer
A Study to Assess the Safety of ARGX-109 in Healthy Volunteers
This study aims to assess the safety of ARGX-109 in healthy adults. Another aim is to measure the amount of ARGX-109 in the blood over time to learn how it moves through the body and acts in the body.
- Trial name
- NCT06799416
- Testing
- ARGX-109
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteers
A Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-119 in Healthy Participants
This phase 1 study is an FIH, double-blinded, placebo-controlled study investigating the safety, tolerability, PK, and immunogenicity of ARGX 119 administered as single doses (IV or SC) or multiple doses (IV) to healthy…
- Trial name
- NCT05670704
- Testing
- ARGX-119
- Where
- Netherlands
- Volunteers
- 112 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
Healthy Volunteers
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
A phase 1 study in healthy volunteers (female and male) to evaluate through SAD and MAD, the safety, PK, PD and immunogenicity of ARGX-113 administered intravenously.
- Trial name
- NCT03457649
- Testing
- ARGX-113
- Volunteers
- 62 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 Volunteers
SAD and MAD Study With IV and SC Doses of ARGX-117
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…
- Trial name
- ARGX-117 (NCT04532125)
- Testing
- ARGX-117, ARGX-117 + rHuPH20, ARGX-117 PH20 SC
- Where
- Netherlands
- Volunteers
- 110 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
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
Bioavailability Study
A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects
The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an Intravenous Formulation of ARGX-113 in Healthy Male…
- Trial name
- NCT03334084
- Testing
- ARGX-113
- Where
- Netherlands
- Volunteers
- 40 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