The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) dose of JNJ-26366821.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
33
Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).
Participants will receive sodium chloride injection as placebo on Day 1.
Harbor Hospital
Baltimore, Maryland, United States
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.
Time frame: Up to Day 30
Maximum Observed Plasma Concentration (Cmax) of JNJ-26366821
Cmax is defined as the maximum observed plasma concentration of JNJ- 26366821.
Time frame: 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 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: Baseline up to Day 30