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| ID | Type | Description | Link |
|---|---|---|---|
| 26366821RSS1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) dose of JNJ-26366821.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1: JNJ-2636682/Placebo | Experimental | Participants will receive single dose of JNJ-26366821 or placebo on Day 1. |
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| Cohort 2: JNJ-26366821/Placebo | Experimental | Participants will receive single dose of JNJ-26366821 or placebo on Day 1. |
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| Cohort 3: JNJ-26366821/Placebo | Experimental | Participants will receive single dose of JNJ-26366821 or placebo. The dose of JNJ-26366821 will be selected based on the safety, pharmacodynamics, and pharmacokinetics data from the previous Cohorts 1 and 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-26366821 | Drug | Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC). |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability | 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 Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-26366821 | Cmax is defined as the maximum observed plasma concentration of JNJ- 26366821. | Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30 |
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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 |
|---|---|---|---|---|---|---|
| Harbor Hospital | Baltimore | Maryland | 21225 | United States |
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 |
|---|---|
| C539273 | RWJ 800088 |
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| Placebo | Drug | Participants will receive sodium chloride injection as placebo on Day 1. |
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| Area Under the Plasma Concentration Versus Time Curve from Time 0 to Time of the Last Measurable Concentration AUC0-Last of JNJ-26366821 |
AUC 0-last is defined as area under the plasma concentration versus time curve from time 0 to time of the last measurable concentration of JNJ-26366821 will be assessed. |
| Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30 |
| Apparent Elimination Half-Life (t1/2) of JNJ-26366821 | T1/2 is define as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve. | Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30 |
| Area Under the JNJ-26366821 Concentration Versus Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-26366821 | AUC (0-infinity) is defined as area under the JNJ-26366821 concentration Versus time curve from Time 0 to infinite time. | Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30 |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-26366821 | Tmax is defined as time to reach the maximum observed plasma JNJ-26366821 concentration. | Day 1: predose, 1, 4, 12 hours (hrs) postdose; Day 2: 24 and 36 hrs postdose; Day 3: 48 and 60 hrs postdose; Day 4: 72 hrs postdose; Day 5: 96 hrs; Day 6: 120 hrs postdose; Days 15 and 30 |
| Change in Platelet Count from Baseline at Each Dose and Time | Change from baseline in platelet count at each dose and time will be assessed. | Baseline up to Day 30 |