Clinical Trials Directory

Trials / Completed

CompletedNCT04564066

A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

A Phase 1, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Multiple Intravenous Infusions of Efgartigimod With Multiple Subcutaneous Injections of Efgartigimod PH20 SC in Healthy Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
54 (actual)
Sponsor
argenx · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.

Conditions

Interventions

TypeNameDescription
BIOLOGICALefgartigimod IVintravenous infusions of efgartigimod
BIOLOGICALefgartigimod PH20 SCsubcutaneous injections of efgartigimod PH20 SC

Timeline

Start date
2020-08-18
Primary completion
2020-12-24
Completion
2021-02-11
First posted
2020-09-25
Last updated
2021-04-05

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT04564066. Inclusion in this directory is not an endorsement.

A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigi (NCT04564066) · Clinical Trials Directory