A Study to Assess the Safety of ARGX-124 in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARGX-124, Placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX-124 in Healthy Adult Participants
Overview
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.
Interventions
- Biological ARGX-124
Administrations of ARGX-124 - Other Placebo
Administrations of placebo comparator
Primary outcome measures
- Incidence of AEs, SAEs and AEs leading to ARGX-124 discontinuation [Time frame: Up to 23 weeks]
Secondary outcome measures (3)
- Maximum observed serum concentration (Cmax) [Time frame: Up to 23 weeks]
- Percent change from baseline in total IgG levels in serum over time [Time frame: Up to 23 weeks]
- Incidence of ADA against ARGX-124 in serum [Time frame: Up to 23 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Altasciences — Montreal
Identifiers
NCT: NCT07377396 · ARGX-124-1-HV-1001