Healthy Volunteers
Conditions
Brief summary
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.
Interventions
BIOLOGICALARGX-113 with rHuPH20
subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)
Sponsors
argenx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IgG levels of four different subcutaneous dose levels | Up to 11 weeks, from study start until the end of the study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Number of (serious) adverse events | Up to 11 weeks, from study start until the end of the study |
Countries
Netherlands
Outcome results
None listed