Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

argenx

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: ARGX-113 with rHuPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT04073589

ARGX-113-1901

2019-002102-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is male, between 18 to 70 years of age
2. Subject is healthy
3. Subject has a body mass index (BMI) between 18 kg/m2 to 30 kg/m2
4. Subject is willing and able to understand the purpose and risks of the trial and provide signed and dated informed consent,
5. Others as defined in the protocol

Exclusion criteria

1. Previous participation in clinical trials with efgartigimod and/or any products with rHuPH20.
2. Known hypersensitivity to IMP ingredients or history of a severe allergic or anaphylactic reaction to any drug as determined by the investigator.
3. 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).
4. Known clinically relevant immunological disorders.
5. Known history or any symptom of clinically significant illness in the 6 months before IMP administration.
6. Others as defined in the protocol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 4 patient groups

Treatment A

Experimental group

Description:

Single SC injection of Dose A

Treatment:

Biological: ARGX-113 with rHuPH20

Treatment B

Experimental group

Description:

Single SC injection of Dose B

Treatment:

Biological: ARGX-113 with rHuPH20

Treatment C

Experimental group

Description:

Single SC injection of Dose C

Treatment:

Biological: ARGX-113 with rHuPH20

Treatment D

Experimental group

Description:

Single SC injection of Dose D

Treatment:

Biological: ARGX-113 with rHuPH20