A phase 1, randomized, open-label, parallel-group study to compare the pharmacodynamics, pharmacokinetics, safety, and tolerability of multiple intravenous infusions of efgartigimod with multiple subcutaneous injections of efgartigimod PH20 SC in healthy subjects.

Completed

Conditions: Auto immune diseases
10003816

Registration Number: NL-OMON49985

Lead Sponsor: argenx BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 54

Inclusion Criteria

Healthy, adult males and females of non-childbearing potential between 18-65
years of age, inclusively, with a BMI between 18-30 kg/m2, and body weight
between 50-100 kg.

Exclusion Criteria

1. The subject has previously participated in clinical studies with
efgartigimod (ARGX-113).
2. The subject has a known hypersensitivity to one of the components in the
IMP, or a history of severe allergic or anaphylactic reactions, in the opinion
of the investigator.
3. The subject tests positively at screening for any of the following
conditions:
a. an active hepatitis B infection (acute or chronic) at screening as
determined by HepB serology
b. Hepatitis C Virus (HCV): serology positive for HCV-Ab
c. HIV positive serology
4. Subjects with clinically significant active or chronic uncontrolled
bacterial, viral, or fungal infection at screening.
5. Subjects with clinical evidence of other significant serious diseases,
subjects who underwent a recent major surgery, or any other reason which could
confound the results of the trial or put the subject at undue risk.
For more exclusion criteria see Protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To demonstrate that the pharmacodynamic (PD) effect of 4 once weekly<br /><br>subcutaneous (SC) injections of 1000 mg efgartigimod PH20 SC is noninferior to<br /><br>that of 4 once weekly intravenous infusions (IV) of efgartigimod at a dose of<br /><br>10 mg/kg by comparing the percentage reduction in total IgG levels after 4<br /><br>weeks (day 29), ie, one week after the 4th administration, using a<br /><br>noninferiority margin of 10%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To further compare the PD effect of efgartigimod IV and efgartigimod PH20 SC<br /><br>over time<br /><br>- To evaluate the pharmacokinetics (PK) of efgartigimod IV and efgartigimod<br /><br>PH20 SC<br /><br>- To evaluate the safety, tolerability, and immunogenicity of efgartigimod IV<br /><br>and of efgartigimod PH20 SC</p><br>