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

argenx1 site in 1 country33 target enrollmentJuly 17, 2019

ConditionsHealthy Volunteers

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: argenx
Enrollment: 33
Locations: 1
Primary Endpoint: IgG levels of four different subcutaneous dose levels
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 17, 2019

End Date

September 26, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

argenx

Responsible Party

Sponsor

Eligibility Criteria

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 rHuPH
•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

Outcomes

Primary Outcomes

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

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)
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)
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)
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)
Number of (serious) adverse events(Up to 11 weeks, from study start until the end of the study)