reduced neuromuscular transmission and muscle weakness debilitating muscle weakness
Conditions
Interventions
Part A
The compound is given once on Day 1
in Groups 1 to 9 as an intravenous infusion for 1 hour: doses between 0.005
mg/kg and 15.0 mg/kg ARGX-119 or placebo
and in group 10 as an injection under
Sponsors
argenx BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply 1. Has reached the age of consent at the time of signing the informed consent form but is
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if any of the following criteria apply: 1. Has a known hypersensitivity to any of the components of the IMP, or has a history of a significant allergic reaction to any drug that is considered exclusionary by the investigator 2. Has been given an investigational product within 3 months or 5 half-lives (whichever is longer) before their first IMP administration if known 3. Has a positive serum test at screening for an active infection with any of the following conditions: a. HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test b. HCV based on HCV antibody assay unless a negative RNA test is available c. HIV based on test results 4. Has a positive COVID-19 test result on day -1, if performed. COVID-19 testing will be performed if considered necessary by the PI or required locally. 5. Has a history of any medical or psychiatric condition that, in the opinion of the investigator, is clinically meaningful, may confound the result of the study, or may pose additional risks to the participant while taking part in the study further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of adverse events, clinical laboratory tests, electrocardiograms, and vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of ARGX 119 Incidence and prevalence of antidrug antibodies against ARGX-119 | — |
Countries
Netherlands
Outcome results
None listed