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CompletedNCT04073589Updated Dec 30, 2019

Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

A Phase 1 interventional study of ARGX-113 with rHuPH20 in Healthy Volunteers, sponsored by argenx. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-30.

Sponsored by argenx · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

argenx is the lead sponsor of 87 studies on the registry; 33 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 16 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Treatment A

    Single SC injection of Dose A

    Biological: ARGX-113 with rHuPH20

  • Experimental
    Treatment B

    Single SC injection of Dose B

    Biological: ARGX-113 with rHuPH20

  • Experimental
    Treatment C

    Single SC injection of Dose C

    Biological: ARGX-113 with rHuPH20

  • Experimental
    Treatment D

    Single SC injection of Dose D

    Biological: ARGX-113 with rHuPH20

Interventions

  • BiologicalARGX-113 with rHuPH20

    subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)

    Also known as: efgartigimod with rHuPH20

06

What researchers measure

Primary outcomes

  1. IgG levels of four different subcutaneous dose levels

    Time frame: Up to 11 weeks, from study start until the end of the study

Secondary outcomes

  1. Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20

    Time frame: Up to 11 weeks, from study start until the end of the study

  2. Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20

    Time frame: Up to 11 weeks, from study start until the end of the study

  3. Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20

    Time frame: Up to 11 weeks, from study start until the end of the study

  4. Number of (serious) adverse events

    Time frame: Up to 11 weeks, from study start until the end of the study

  5. Level of anti-drug antibodies

    Time frame: Up to 11 weeks, from study start until the end of the study

  6. Time required to administer the different doses

    Time frame: Up to 11 weeks, from study start until the end of the study

07

Study locations

1 site
  • Investigator Site
    Groningen, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04073589
Lead sponsor
argenx
Responsible party
Sponsor
First posted
Aug 29, 2019
Start date
Jul 17, 2019
Primary completion
Sep 26, 2019
Completion
Sep 26, 2019
Last update
Dec 30, 2019

Study contacts

Antonio Guglietta, MD
study director · argenx

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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