A Study of Nipocalimab With Co-administration of Etanercept or Hydroxychloroquine in Healthy Participants

Janssen Research & Development, LLC48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

NipocalimabDRUG

Nipocalimab will be administered as an IV infusion.

EtanerceptDRUG

Etanercept will be administered subcutaneously.

HydroxychloroquineDRUG

HCQ will be administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are any abnormalities, they must be consistent with the underlying illness in the study population or considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator * Healthy on the basis of clinical laboratory tests performed at screening (including immunoglobulin \[Ig\]G) and at admission to the study site. If the results of the serum chemistry panel, liver panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator * Good venous access in both arms * Participants must have heart rate of at least 50 beats per minute * Participant is considered eligible according to the following tuberculosis (TB) screening criteria (for Part 1 only): a) have no history of latent or active TB before screening; b) have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; c) have had no recent close contact with a person with active TB; d) have a negative QuantiFERON-TB test result within 28 days prior to the administration of study intervention * Part 1: Body mass index (BMI) greater than or equal to (\>=) 18.0 to less than or equal to (\<=) 30.0 kilogram (kg)/meter (m)\^2 (inclusive), and body weight \>= 50 to \<= 110.0 kg (inclusive) at the screening visit and on Day -1; Part 2: BMI \>= 18.0 to \<= 30.0 kg/m\^2 (inclusive), and body weight \>= 61.5 to \<= 110.0 kg (inclusive) at the screening visit and on Day -1 * A female participant must have a negative serum (beta-human chorionic gonadotropin) test at screening and a urine pregnancy test at Day -1 prior to administration of study intervention * It is recommended that participants are up to date on age-appropriate vaccinations prior to screening per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, applicable local vaccine labeling, guidelines, and standards of care for participants receiving immune-targeted therapy should be followed when determining an appropriate interval between vaccination and study enrollment Exclusion Criteria: * Has a history of liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * Has a history of retinal and macular disease (only for Part 2) * Has shown a previous severe immediate hypersensitivity reaction response, including anaphylaxis, to therapeutic proteins (example, monoclonal antibody \[mAbs\]) * Has serum albumin levels \< 30 grams/Liter (g/L) at screening and Day -1 * Has a history of myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks prior to screening

Locations (1)

PRA Health Sciences

Groningen, Netherlands

Outcomes

Primary Outcomes

Part 1: Serum Etanercept Concentration

Serum etanercept concentration will be reported.

Time frame: Up to Day 99

Part 1: Ratio of Area Under the Concentration-time Curve (AUCR) of Etanercept

AUCR is defined as the ratio of area under the concentration-time curve.

Time frame: Up to Day 99

Part 1: Area Under the Concentration-time Curve of Etanercept from Time Zero to Time of Last Observed Quantifiable Concentration (AUC [0-Last])

AUC (0-last) is defined as area under the concentration-time curve of etanercept from time zero to time of last observed quantifiable concentration.

Time frame: Up to Day 99

Part 1: Area Under the Concentration-time Curve of Etanercept from Time Zero to Infinite time (AUC [0-Infinity])

AUC (0-Infinity) is defined as area under the concentration-time curve of etanercept from time zero to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z) where AUC (0-last) is area under the concentration-time curve of etanercept from time zero to time of last observed quantifiable concentration and C(last) is the last observed quantifiable concentration, and lambda(z) is apparent terminal elimination rate constant.

Time frame: Up to Day 99

Part 1: Maximum Observed Concentration (Cmax) of Etanercept

Cmax is defined as maximum observed concentration of etanercept.

Time frame: Up to Day 99

Part 1: Ratio of Maximum Observed Concentration (CmaxR) of Etanercept

CmaxR is defined as ratio of maximum observed concentration of etanercept.

Time frame: Up to Day 99

Part 1: Time to Reach the Last Observed Measurable Analyte Concentration (Tlast) of Etanercept

Data from ClinicalTrials.gov

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Secondary Outcomes

Part 1: Number of Participants with Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Time frame: Up to 4 months

Part 1: Number of Participants with Abnormalities in Physical Examinations

Number of participants with abnormalities in physical examinations (full and brief) will be reported. Full physical examinations will include a review of the following body systems: general appearance; thorough skin and oral mucosa evaluation; eyes, ears, nose, and throat; cardiovascular; respiratory; abdomen; peripheral pulsation; lymph nodes; neurologic; musculoskeletal; head, neck, and thyroid. A brief physical examination includes review of the following body systems: general appearance, thorough skin (including site of the injection) and oral mucosa, abdomen, respiratory, cardiovascular, any abnormalities noted on previous examinations.

Time frame: Up to 4 months

Part 1: Number of Participants with Abnormalities in Vital Sign Measurements

Number of participants with abnormalities in vital sign measurements (body temperature \[temporal artery measurement\], pulse/heart rate, respiratory rate, blood pressure) will be reported.

Time frame: Up to 4 months

Part 1: Number of Participants with Abnormalities in Clinical Laboratory Tests

Number of participants with abnormalities in clinical laboratory tests (serum chemistry, liver panel, hematology, and urinalysis) will be reported.

Time frame: Up to 4 months

Parts 1 and 2: Serum Nipocalimab Concentrations

Serum nipocalimab concentrations will be reported.