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Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

NCT ID: NCT04073589

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-17

Study Completion Date

2019-09-26

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treatment A

Single SC injection of Dose A

Group Type EXPERIMENTAL

ARGX-113 with rHuPH20

Intervention Type BIOLOGICAL

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

Treatment B

Single SC injection of Dose B

Group Type EXPERIMENTAL

ARGX-113 with rHuPH20

Intervention Type BIOLOGICAL

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

Treatment C

Single SC injection of Dose C

Group Type EXPERIMENTAL

ARGX-113 with rHuPH20

Intervention Type BIOLOGICAL

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

Treatment D

Single SC injection of Dose D

Group Type EXPERIMENTAL

ARGX-113 with rHuPH20

Intervention Type BIOLOGICAL

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

Interventions

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ARGX-113 with rHuPH20

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

Intervention Type BIOLOGICAL

Other Intervention Names

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efgartigimod with rHuPH20

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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argenx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Guglietta, MD

Role: STUDY_DIRECTOR

argenx

Locations

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Investigator Site

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2019-002102-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ARGX-113-1901

Identifier Type: -

Identifier Source: org_study_id