A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: JNJ-26366821
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overall good health, on the basis of full physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening Body weight 50 - 100 kilogram (kg), body mass index (BMI) 18 - 30 kilogram per meter square (kg/m^2), inclusive at screening Platelet count within range: 145 to 350*10^9/liter (L), inclusive at screening Hematologic values, coagulation profile, renal and liver function within normal range at screening or if out of range and considered not clinically significant by the investigator Non-smoker for at least the previous 3 months prior to screening and negative urine cotinine test at screening and admission Exclusion Criteria: History of any clinically significant medical illness or disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease Has a disease or disease treatment history associated with immune suppression or lymphopenia, these include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenism, and chronic granulomatous disease Has a personal history of genetic or congenital prothrombotic condition or new conditions associated with thromboembolic events or bleeding disorders, including (but not limited to) myocardial infarction, cerebral vascular accident/stroke, deep vein thrombosis, pulmonary embolism, hemophilia, or menometrorrhagia Participants who had received hematopoietic growth factors within 3 months prior to study drug administration Donation of blood or blood components within 90 days prior to drug administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort1: JNJ-2636682/Placebo<br>Participants will receive single dose of JNJ-26366821 or placebo on Day 1. | Drug: JNJ-26366821<br>* Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).<br>Drug: Placebo<br>* Participants will receive sodium chloride injection as placebo on Day 1.<br>|
| Experimental: Cohort 2: JNJ-26366821/Placebo<br>Participants will receive single dose of JNJ-26366821 or placebo on Day 1. | Drug: JNJ-26366821<br>* Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).<br>Drug: Placebo<br>* Participants will receive sodium chloride injection as placebo on Day 1.<br>|
| Experimental: Cohort 3: JNJ-26366821/Placebo<br>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. | Drug: JNJ-26366821<br>* Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).<br>Drug: Placebo<br>* Participants will receive sodium chloride injection as placebo on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |