Clinical trial NCT04073589: Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2019-08-29
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: IgG levels of four different subcutaneous dose levels
timeFrame: Up to 11 weeks, from study start until the end of the study
Secondary outcomes:
measure: Maximum serum concentrations (Cmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
timeFrame: Up to 11 weeks, from study start until the end of the study
measure: Time to reach maximum serum concentrations (Tmax) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
timeFrame: Up to 11 weeks, from study start until the end of the study
measure: Area Under The Curve (AUC) of four different subcutaneous dose levels of efgartigimod co-administered with rHuPH20
timeFrame: Up to 11 weeks, from study start until the end of the study
measure: Number of (serious) adverse events
timeFrame: Up to 11 weeks, from study start until the end of the study
measure: Level of anti-drug antibodies
timeFrame: Up to 11 weeks, from study start until the end of the study
measure: Time required to administer the different doses
timeFrame: Up to 11 weeks, from study start until the end of the study
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Investigator Site
Study officials:
affiliation: argenx
name: Antonio Guglietta, MD
role: STUDY_DIRECTOR
References: