Status:
COMPLETED
A Study of Nipocalimab in Healthy Male and Female Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of nipocalimab following subcutaneous (SC) administration compared with intravenous (IV) administratio...
Eligibility Criteria
Inclusion
- Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
- Healthy on the basis of clinical laboratory tests performed at screening
- Continuous non-smoker
- A woman of childbearing potential must have a negative pregnancy test
- It is recommended that participants are up to date on all age appropriate vaccinations prior to screening as per routine local medical guidelines
Exclusion
- Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Currently has a malignancy or has a history of malignancy within 3 years before screening
- Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Has received a live vaccine within 3 months prior to screening or has a known need to receive a live vaccine during the study, or within at least 3 months after the last administration of study intervention in this study
- Shows evidence of an active or chronic hepatitis B infection
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2022
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04848558
Start Date
May 25 2021
End Date
May 26 2022
Last Update
July 3 2023
Active Locations (1)
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1
PRA Health Sciences
Groningen, Netherlands, NZ 9728