MedTrace Logo

Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects

NCT04073589 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2019-12-30

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ARGX-113 with rHuPH20

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

Sponsors & Collaborators

Principal Investigators

  • Antonio Guglietta, MD · argenx

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2019-09-26
Completion
2019-09-26

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04073589 on ClinicalTrials.gov