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.

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. - Comparing PK, PD, safety of efgartigimod SC and IV.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49985

Enrollment

Registered

2020-03-09

Start date

2020-08-18

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auto immune diseases

Interventions

Efgartigimod will be given as either an intravenous infusion (solution of the compound that will be administered directly in a blood vessel) or as an injection under the skin (subcutaneous).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
To further compare the PD effect of efgartigimod IV and efgartigimod PH20 SC over time - To evaluate the pharmacokinetics (PK) of efgartigimod IV and efgartigimod PH20 SC - To evaluate the safety, tolerability, and immunogenicity of efgartigimod IV and of efgartigimod PH20 SC	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)