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OpenTrials
Completed

NCT Number: NCT04073589

Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

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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Key information

Conditions

Healthy Volunteers

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARGX-113 with rHuPH20

Biological

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

Other names: efgartigimod with rHuPH20

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

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2019
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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