autoimmune diseases
Conditions
Interventions
Part A:
In Groups 1 to 8, ARGX-117 or placebo will be given as a 2-hour intravenous
infusion or ARGX-117 or placebo will be given in combination with rHuPH20 will
as an injection under the skin (sub
Sponsors
argenx BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The subject is between 18-65 years of age, inclusive, at the time the informed consent form is signed. 2. The subject is either male or female of non-childbearing potential. Females in the following categories are considered a woman of non-childbearing potential: a. Postmenopausal female: A postmenopausal state is defined as continuous amenorrhea for at least 1 year without an alternative medical cause and a follicle-stimulating hormone (FSH) measurement of >40 IU/L. A historical pretreatment FSH measurement of >40 IU/L is accepted as proof of a postmenopausal state for subjects on hormone replacement therapy. b. Surgically sterile female: women who have had a documented permanent sterilization procedure (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). 3. Female subjects must have a negative serum pregnancy test on day -1 before IMP can be administered. 4. The subject has a body mass index (BMI) within the range 18-30 kg/m2 and body weight 50-100 kg (inclusive) before IMP administration. 5. The subject is able to understand the requirements of the trial and provide written informed consent (including consent for the use and disclosure of research-related health information) and is willing and able to comply with the trial protocol procedures (including the required trial visits). Further criteria apply.
Exclusion criteria
Exclusion criteria: 1. The subject has a known hypersensitivity to one of the components of the IMP, or, in the opinion of the investigator, a history of a significant allergic reaction to any drug. 2. The subject has previously participated in a clinical trial with efgartigimod and was administered an IMP. 3. The subject has a positive serum test at screening for an active viral infection with any of the following conditions: a. Hepatitis B virus (HBV) that is indicative of an acute or chronic infection b. Hepatitis C virus (HCV) based on HCV antibody assay c. Human immunodeficiency virus (HIV) 4. The subject tests positively at screening for SLE as determined by the SLE test panel. 5. The subject has a known family history of SLE. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A (single ascending dose [SAD]): To evaluate the safety and tolerability of single ascending intravenous (IV) doses of ARGX-117 and subcutaneous (SC) doses of ARGX-117 co-mixed with recombinant human hyaluronidase PH20 (rHuPH20) in healthy adult subjects, compared to placebo. Part B (multiple ascending dose [MAD]): To evaluate the safety and tolerability of multiple ascending IV doses of ARGX-117 and SC doses of ARGX-117 co-mixed with rHuPH20 in healthy adult subjects, compared to placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A (SAD): To investigate the pharmacokinetics (PK), pharmacodynamic (PD), and immunogenicity effects of single ascending IV doses of ARGX-117 and SC doses of ARGX-117 co-mixed with rHuPH20 in healthy adult subjects. Part B (MAD): To investigate the PK, PD, and immunogenicity effects of multiple ascending IV doses of ARGX-117 and SC doses of ARGX-117 co-mixed with rHuPH20 in healthy adult subjects. | — |
Countries
Netherlands
Outcome results
None listed