Clinical trial NCT04848558: A Study of Nipocalimab in Healthy Male and Female Participants
Official title: A Phase 1 Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Nipocalimab in Healthy Male and Female Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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) administration in healthy participants.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to Day 85
measure: Percentage of Participants with Serious Adverse Event (SAE)
timeFrame: Up to Day 85
measure: Percentage of Participants with Reasonably Related AEs
timeFrame: Up to Day 85
measure: Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Day 85
measure: Percentage of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Up to Day 85
measure: Number of Participants with Vital Signs Abnormalities
timeFrame: Up to Day 85
measure: Number of Participants with Electrocardiogram (ECG) Abnormalities
timeFrame: Up to Day 85
measure: Number of Participants with Clinical Laboratory Abnormalities
timeFrame: Up to Day 85
measure: Number of Participants with Subcutaneous (SC) Injection-site Reactions
timeFrame: Up to Day 85
Secondary outcomes:
measure: Serum Concentration of Nipocalimab
timeFrame: Up to Day 85
measure: Change from Baseline in Immunoglobulin (Ig) Levels Over Time
timeFrame: Baseline to Day 85
measure: Number of Participants with Antibodies to Nipocalimab
timeFrame: Up to Day 85
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: