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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002102-40 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single SC injection of Dose A |
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| Treatment B | Experimental | Single SC injection of Dose B |
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| Treatment C | Experimental | Single SC injection of Dose C |
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| Treatment D | Experimental | Single SC injection of Dose D |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGX-113 with rHuPH20 | Biological | subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20) |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Guglietta, MD | argenx | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site | Groningen | Netherlands |
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| ID | Term |
|---|---|
| C000718373 | efgartigimod alfa |
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|
| 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 |