Trials / Completed
CompletedNCT04073589
Efgartigimod Co-administered Subcutaneously With rHuPH20 in Healthy Subjects
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- argenx · Industry
- Sex
- Male
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ARGX-113 with rHuPH20 | subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20) |
Timeline
- Start date
- 2019-07-17
- Primary completion
- 2019-09-26
- Completion
- 2019-09-26
- First posted
- 2019-08-29
- Last updated
- 2019-12-30
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04073589. Inclusion in this directory is not an endorsement.