A First-in-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous Dose Levels of ARGX-117 and Subcutaneous Dose Levels of ARGX-117 Co-Mixed with Recombinant Human Hyaluronidase PH20
- Conditions
- autoimmune diseases10003816
- Registration Number
- NL-OMON52853
- Lead Sponsor
- argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 112
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A (single ascending dose [SAD]): To evaluate the safety and tolerability<br /><br>of single ascending intravenous (IV) doses of ARGX-117 and subcutaneous (SC)<br /><br>doses of ARGX-117 co-mixed with recombinant human hyaluronidase PH20 (rHuPH20)<br /><br>in healthy adult subjects, compared to placebo.<br /><br><br /><br>Part B (multiple ascending dose [MAD]): To evaluate the safety and tolerability<br /><br>of multiple ascending IV doses of ARGX-117 and SC doses of ARGX-117 co-mixed<br /><br>with rHuPH20 in healthy adult subjects, compared to placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part A (SAD): To investigate the pharmacokinetics (PK), pharmacodynamic (PD),<br /><br>and immunogenicity effects of single ascending IV doses of ARGX-117 and SC<br /><br>doses of ARGX-117 co-mixed with rHuPH20 in healthy adult subjects.<br /><br><br /><br>Part B (MAD): To investigate the PK, PD, and immunogenicity effects of multiple<br /><br>ascending IV doses of ARGX-117 and SC doses of ARGX-117 co-mixed with rHuPH20<br /><br>in healthy adult subjects. </p><br>