Trials / Completed
CompletedNCT04973566
A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants
A Phase 1, Open-Label Study to Investigate Drug-Drug Interaction (DDI) Potential of Nipocalimab With Coadministration of Etanercept or Hydroxychloroquine in Healthy Participants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The primary purpose of this study is to assess the effect of nipocalimab on the pharmacokinetic (PK) of etanercept (Part 1); and to assess the effect of hydroxychloroquine (HCQ) on total serum immunoglobin G (IgG) reduction by nipocalimab (Part 2) in healthy participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nipocalimab | Nipocalimab will be administered as an IV infusion. |
| DRUG | Etanercept | Etanercept will be administered subcutaneously. |
| DRUG | Hydroxychloroquine | HCQ will be administered orally. |
Timeline
- Start date
- 2021-08-31
- Primary completion
- 2022-05-27
- Completion
- 2022-05-27
- First posted
- 2021-07-22
- Last updated
- 2025-03-04
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT04973566. Inclusion in this directory is not an endorsement.