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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001656-33 | EudraCT Number | ||
| 80202135EDI1003 | Other Identifier | Janssen Research & Development, LLC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Etanercept and Nipocalimab | Experimental | Participants will receive a single subcutaneous (SC) dose of etanercept on Day 1 in Period 1 followed by single intravenous (IV) infusion of nipocalimab on Day 29, SC administration of etanercept followed by an IV infusion of nipocalimab on Day 43 and then a single dose of nipocalimab IV infusion on Day 57 in Period 2 of Part 1. There will be a wash-out period of 28 days between Day 1 of Period 1 and Day 29 of Period 2 in Part 1. |
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| Part 2 (Cohort 1): Nipocalimab | Experimental | Participants will receive a single IV infusion of nipocalimab on Day 1 in Cohort 1 of Part 2. |
|
| Part 2 (Cohort 2): Nipocalimab and Hydroxychloroquine (HCQ) | Experimental | Participants will receive a single oral dose of HCQ film-coated tablets once daily from Day 1 to Day 22 and a single IV infusion of nipocalimab on Day 8 in Cohort 2 of Part 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nipocalimab | Drug | Nipocalimab will be administered as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Serum Etanercept Concentration | Serum etanercept concentration will be reported. | 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. | 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. | 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. | Up to Day 99 |
| Part 1: Maximum Observed Concentration (Cmax) of Etanercept | Cmax is defined as maximum observed concentration of etanercept. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 4 months |
| Part 1: Number of Participants with Abnormalities in Physical Examinations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | NZ 9728 | Netherlands |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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Part 1 is a single-sequence, 2-period study and Part 2 is a randomized, 2-cohort (Cohort 1 and Cohort 2), parallel study.
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| Etanercept | Drug | Etanercept will be administered subcutaneously. |
|
| Hydroxychloroquine | Drug | HCQ will be administered orally. |
|
| Up to Day 99 |
| Part 1: Time to Reach the Last Observed Measurable Analyte Concentration (Tlast) of Etanercept | Tlast is defined as time to reach the last observed measurable analyte concentration of etanercept. | Up to Day 99 |
| Part 1: Time to Reach the Maximum Observed Concentration (Tmax) of Etanercept | Tmax is defined as time to reach the maximum observed concentration of etanercept. | Up to Day 99 |
| Part 1: Elimination Half-life (t1/2) of Etanercept | t1/2 is defined as elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/ lambda(z). | Up to Day 99 |
| Part 1: Total Apparent Clearance (CL/F) of Etanercept | CL/F is total apparent clearance of etanercept following subcutaneous (SC) administration, calculated as dose/AUC (0-infinity). | Up to Day 99 |
| Part 1: Apparent Volume of Distribution (Vdz/F) of Etanercept | Vdz/F is defined as apparent volume of distribution based on the terminal phase after an SC dose, calculated as dose/lambda(z)*AUC(0-infinity). | Up to Day 99 |
| Part 2: Change from Baseline in Total Serum Immunoglobulin (Ig) Levels | Change from baseline in total serum Ig levels (serum IgG and IgG subtypes) through Day 50 will be reported. | Baseline up to Day 50 |
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. |
| 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. | 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. | Up to 4 months |
| Parts 1 and 2: Serum Nipocalimab Concentrations | Serum nipocalimab concentrations will be reported. | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Part 1: AUCR of Nipocalimab | AUCR is defined as the ratio of area under the concentration-time curve. | Up to Day 99 |
| Parts 1 and 2: AUC (0-Last) of Nipocalimab | AUC (0-last) is defined as area under the concentration-time curve of nipocalimab from time zero to time of last observed quantifiable concentration. | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Parts 1 and 2: AUC (0-Infinity) of Nipocalimab | AUC (0-Infinity) is defined as area under the concentration-time curve of nipocalimab 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 nipocalimab 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. | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Parts 1 and 2: Cmax of Nipocalimab | Cmax is defined as maximum observed concentration of nipocalimab. | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Part 1: CmaxR of Nipocalimab | CmaxR is defined as ratio of maximum observed concentration of nipocalimab. | Up to Day 99 |
| Parts 1 and 2: Tlast of Nipocalimab | Tlast is defined as time to reach the last observed measurable analyte concentration of nipocalimab. | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Parts 1 and 2: Tmax of Nipocalimab | Tmax is defined as time to reach the maximum observed concentration of nipocalimab. | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Parts 1 and 2: t1/2 of Nipocalimab | t1/2 is defined as elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve, calculated as 0.693/ lambda(z). | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Parts 1 and 2: Total Systemic Clearance of Nipocalimab (CL) | CL is defined as total systemic clearance of nipocalimab following an intravenous (IV) administration, calculated as dose/AUC (0-infinity). | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Parts 1 and 2: Volume of Distribution (Vdz) of Nipocalimab | Vdz is defined as volume of distribution, based on the terminal phase after an IV dose, calculated as dose/lambda(z)*AUC (0-infinity). | Up to Day 99 (Part 1); up to Day 50 (Part 2) |
| Part 1: Number of Participants with Antibodies to Nipocalimab | Number of participants with antibodies to nipocalimab will be reported. | Up to Day 99 |
| Part 2: Serum Lipid and Albumin Levels | Participants serum lipid and albumin levels will be reported. | Up to Day 50 |
| Part 2: Number of Participants with Receptor Occupancy (RO) Levels of Nipocalimab | Number of Participants with RO levels (example, neonatal Fc receptor [FcRn] RO in circulating monocytes) of nipocalimab will be reported. | Up to Day 50 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |