Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: ARGX-113 with rHuPH20

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Investigator site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A; Single SC injection of Dose A	Biological: ARGX-113 with rHuPH20; subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20); Other Names: efgartigimod with rHuPH20
Experimental: Treatment B; Single SC injection of Dose B	Biological: ARGX-113 with rHuPH20; subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20); Other Names: efgartigimod with rHuPH20
Experimental: Treatment C; Single SC injection of Dose C	Biological: ARGX-113 with rHuPH20; subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20); Other Names: efgartigimod with rHuPH20
Experimental: Treatment D; Single SC injection of Dose D	Biological: ARGX-113 with rHuPH20; subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20); Other Names: efgartigimod with rHuPH20

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: argenx
• Investigators: Study Director: Antonio Guglietta, MD, argenx

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2019
• Primary Completion (Actual): September 26, 2019
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ARGX-113-1901; 2019-002102-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No