Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Biological: ARGX-113 with rHuPH20

• Registration Number: NCT04073589
• Lead Sponsor: argenx

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-17
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-29
• Primary Completion: 2019-09-26
• Study Completion: 2019-09-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment D	ARGX-113 with rHuPH20	Single SC injection of Dose D
Treatment B	ARGX-113 with rHuPH20	Single SC injection of Dose B
Treatment C	ARGX-113 with rHuPH20	Single SC injection of Dose C
Treatment A	ARGX-113 with rHuPH20	Single SC injection of Dose A

Primary Outcome Measures

Name	Time	Method
IgG levels of four different subcutaneous dose levels	Up to 11 weeks, from study start until the end of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Investigator Site; 🇳🇱 Groningen, Netherlands