Status:
COMPLETED
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
Lead Sponsor:
argenx
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-70 years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04073589
Start Date
July 17 2019
End Date
September 26 2019
Last Update
December 30 2019
Active Locations (1)
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1
Investigator Site
Groningen, Netherlands