Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 61178104NAP1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-004253-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose administration and a single Subcutaneous (SC) dose administration in healthy participants.
This is a randomized, double-blind, placebo-controlled, single ascending dose, single site, interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort. Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration of participants participation will be approximately 21 weeks including a Screening Visit up to 4 weeks prior to study drug administration. Participants will have an inpatient period consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9, 13, and 17. Participants will be evaluated for safety throughout the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1: JNJ-61178104 OR Placebo IV | Experimental | Participants will receive either JNJ-61178104 0.1 milligram/kilogram (mg/kg) or Placebo Intravenously (IV) on Day 1. |
|
| Dose 2: JNJ-61178104 OR Placebo IV | Experimental | Participants will receive either JNJ-61178104 0.3 mg/kg or Placebo IV on Day 1. |
|
| Dose 3: JNJ-61178104 OR Placebo IV | Experimental | Participants will receive either JNJ-61178104 1 mg/kg or Placebo IV on Day 1. |
|
| Dose 4: JNJ-61178104 OR Placebo IV | Experimental | Participants will receive either JNJ-61178104 3 mg/kg or Placebo IV on Day 1. |
|
| Dose 5: JNJ-61178104 OR Placebo IV | Experimental | Participants will receive either JNJ-61178104 10 mg/kg or Placebo IV on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-61178104 Intravenous | Drug | Participants will receive JNJ-61178104 Intravenously on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Following Study Drug Administration as a Measure of Safety and Tolerability | Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Concentration of JNJ-61178104 | Up to Day 113 | |
| JNJ-61178104 Antibodies Concentration | Up to Day 113 | |
| Cytokine Concentrations |
Not provided
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merksem | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
| Dose 6: JNJ-61178104 OR Placebo SC | Experimental | Participants will receive either JNJ-61178104 1 mg/kg or Placebo Subcutaneously (SC) on Day 1. |
|
| JNJ-61178104 Subcutaneous | Drug | Participants will receive JNJ-61178104 Subcutaneously on Day 1. |
|
| Placebo | Drug | Participants will receive placebo on Day 1. |
|
| Predose, Up to Day 113 |
| Maximum Observed Serum Concentration (Cmax) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Area Under the Serum Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Serum Half-Life (t1/2) Following Intravenous (IV) and Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Time to Reach Maximum Observed Serum Concentration (Tmax) Following Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Systemic Clearance (CL) Following Intravenous (IV) JNJ-61178104 Administration | Up to Day 113 |
| Apparent Clearance (CL/F) Following Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Volume of Distribution (Vz) Following Intravenous (IV) JNJ-61178104 Administration | Up to Day 113 |
| Apparent Volume of Distribution (Vz/F) Following Subcutaneous (SC) JNJ-61178104 Administration | Up to Day 113 |
| Absolute Bioavailability (F[abs]) Following Subcutaneous (SC) JNJ-61178104 Administration | The F is the percentage of the subcutaneously administered dose that is systemically available relative to an intravenous (IV) administration. It is calculated as (AUC [0-infinity] for 1 mg/kg SC JNJ-61178104)/(AUC [0-infinity] for 1 mg/kg IV JNJ-61178104 )*100, where the AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time. | Up to Day 113 |