NCT04073589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

August 16, 2019

Last Update Submit

December 27, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • IgG levels of four different subcutaneous dose levels

    Up to 11 weeks, from study start until the end of the study

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

Treatment A

EXPERIMENTAL

Single SC injection of Dose A

Biological: ARGX-113 with rHuPH20

Treatment B

EXPERIMENTAL

Single SC injection of Dose B

Biological: ARGX-113 with rHuPH20

Treatment C

EXPERIMENTAL

Single SC injection of Dose C

Biological: ARGX-113 with rHuPH20

Treatment D

EXPERIMENTAL

Single SC injection of Dose D

Biological: ARGX-113 with rHuPH20

Interventions

ARGX-113 with rHuPH20BIOLOGICAL

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

Also known as: efgartigimod with rHuPH20
Treatment ATreatment BTreatment CTreatment D

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous participation in clinical trials with efgartigimod and/or any products with rHuPH20.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigator Site

Groningen, Netherlands

Location

MeSH Terms

Interventions

efgartigimod alfa

Study Officials

  • Antonio Guglietta, MD

    argenx

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 29, 2019

Study Start

July 17, 2019

Primary Completion

September 26, 2019

Study Completion

September 26, 2019

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations

NL(1)