A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
Sponsorargenx
About this trial
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. Participants will remain in the study for up to approximately 23 weeks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.
Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male.
Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, inclusive.
Disqualifiers
Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
Has IgG levels <6.0 g/L at screening.
Has a history of an immunosuppressive disease or an immunosuppressive condition at screening.
Previously participated in an ARGX-124, ARGX-213, or efgartigimod clinical study and received at least 1 dose of the study drug.
Trial design
Design model
Parallel
Treatments tested in this trial
ARGX-124
Biological/VaccineAdministrations of ARGX-124
Placebo
Other interventionAdministrations of placebo comparator
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: ARGX-124Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation
AE : adverse event ; SAE : serious adverse event.
Time frame
Up to 23 weeksSecondary outcomes
1
Maximum observed serum concentration (Cmax)
Time frame
Up to 23 weeks2
Percent change from baseline in total IgG levels in serum over time
IgG : immunoglobulin G
Time frame
Up to 23 weeks3
Incidence of ADA against ARGX-124 in serum
ADA : anti-drug antibodies
Time frame
Up to 23 weeks Source ClinicalTrials.gov