Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

Study Overview
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Brief Summary
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The aim of this trial is to investigate the pharmacodynamic (PD), pharmacokinetic (PK), safety, tolerability, and immunogenicity of efgartigimod co-administered with rHuPH20, and to measure the time to inject the full dose of investigational medicinal product (IMP) of different dose levels of efgartigimod co-administered with a fixed concentration of rHuPH20 by the subcutaneous (SC) route of administration in healthy adult male subjects.

Official Title
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A Phase 1, Randomized, Open-label, Parallel-group Trial to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Different Single Subcutaneous Dose Levels of Efgartigimod Co-administered With rHuPH20 in Healthy Adult Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Biological: ARGX-113 with rHuPH20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male, between 18 to 70 years of age Subject is healthy Subject has a body mass index (BMI) between 18 kg/m2 to 30 kg/m2 Subject is willing and able to understand the purpose and risks of the trial and provide signed and dated informed consent, Others as defined in the protocol Exclusion Criteria: Previous participation in clinical trials with efgartigimod and/or any products with rHuPH20. Known hypersensitivity to IMP ingredients or history of a severe allergic or anaphylactic reaction to any drug as determined by the investigator. Known seropositivity or positive test at screening for an active viral infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human immunodeficiency virus (HIV). Known clinically relevant immunological disorders. Known history or any symptom of clinically significant illness in the 6 months before IMP administration. Others as defined in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single SC injection of Dose A | Biological: ARGX-113 with rHuPH20<br>* subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)<br>* Other names: efgartigimod with rHuPH20;|
| Experimental: Treatment B<br>Single SC injection of Dose B | Biological: ARGX-113 with rHuPH20<br>* subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)<br>* Other names: efgartigimod with rHuPH20;|
| Experimental: Treatment C<br>Single SC injection of Dose C | Biological: ARGX-113 with rHuPH20<br>* subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)<br>* Other names: efgartigimod with rHuPH20;|
| Experimental: Treatment D<br>Single SC injection of Dose D | Biological: ARGX-113 with rHuPH20<br>* subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)<br>* Other names: efgartigimod with rHuPH20;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG levels of four different subcutaneous dose levels |  | Up to 11 weeks, from study start until the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 |  | Up to 11 weeks, from study start until the end of the study | 
| Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 |  | Up to 11 weeks, from study start until the end of the study | 
| Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20 |  | Up to 11 weeks, from study start until the end of the study | 
| Number of (serious) adverse events |  | Up to 11 weeks, from study start until the end of the study | 
| Level of anti-drug antibodies |  | Up to 11 weeks, from study start until the end of the study | 
| Time required to administer the different doses |  | Up to 11 weeks, from study start until the end of the study |