Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073589
• Other study ID #: ARGX-113-1901
• Secondary ID: 2019-002102-40
• Status: Completed
• Phase: Phase 1
• Start date: July 17, 2019
• Est. completion date: September 26, 2019

Study information

• Verified date: December 2019
• Source: argenx BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 26, 2019
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• ARGX-113 with rHuPH20
subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)

Locations

Country	Name	City	State
Netherlands	Investigator Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
argenx BVBA

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IgG levels of four different subcutaneous dose levels		Up to 11 weeks, from study start until the end of the study
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of (serious) adverse events		Up to 11 weeks, from study start until the end of the study
Secondary	Level of anti-drug antibodies		Up to 11 weeks, from study start until the end of the study
Secondary	Time required to administer the different doses		Up to 11 weeks, from study start until the end of the study