A Phase 1, Randomized, Double Blinded, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of ARGX 119 in Healthy Participants
- Conditions
- reduced neuromuscular transmission and muscle weaknessdebilitating muscle weakness10029317
- Registration Number
- NL-OMON53520
- Lead Sponsor
- argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 116
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 <=65 years of age
2. Is capable of providing signed informed consent and understands and is
capable of complying with protocol requirements
3. Is a healthy, defined as having no clinically meaningful abnormalities
identified in any of the following assessments before the first IMP
administration on day 1: medical history, physical examination, standard
12-lead ECG, vital sign measurements, and clinical laboratory tests
4. Is either male or a female of nonchildbearing potential.
5. Has negative serum pregnancy tests at both screening and on day -1 (female
participants)
further criteria apply
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessment of adverse events, clinical laboratory tests, electrocardiograms,<br /><br>and vital signs</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetic parameters of ARGX 119<br /><br>Incidence and prevalence of antidrug antibodies against ARGX-119</p><br>