Clinical Trials/NCT03990519

NCT03990519

Completed

Phase 1

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

Janssen Research & Development, LLC1 site in 1 country33 target enrollmentJune 24, 2019

ConditionsHealthy

InterventionsJNJ-26366821 Placebo

DrugsJNJ-26366821 Placebo

Overview

Phase: Phase 1
Intervention: JNJ-26366821
Conditions: Healthy
Sponsor: Janssen Research & Development, LLC
Enrollment: 33
Locations: 1
Primary Endpoint: Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) dose of JNJ-26366821.

Registry

clinicaltrials.gov

Start Date

June 24, 2019

End Date

February 19, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Janssen Research & Development, LLC

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Cohort1: JNJ-2636682/Placebo

Participants will receive single dose of JNJ-26366821 or placebo on Day 1.

Intervention: JNJ-26366821

Cohort1: JNJ-2636682/Placebo

Participants will receive single dose of JNJ-26366821 or placebo on Day 1.

Intervention: Placebo

Cohort 2: JNJ-26366821/Placebo

Participants will receive single dose of JNJ-26366821 or placebo on Day 1.

Intervention: JNJ-26366821

Cohort 2: JNJ-26366821/Placebo

Participants will receive single dose of JNJ-26366821 or placebo on Day 1.

Intervention: Placebo

Cohort 3: JNJ-26366821/Placebo

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.

Intervention: JNJ-26366821

Cohort 3: JNJ-26366821/Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability

Time Frame: Up to Day 30

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.

Secondary Outcomes

Apparent Elimination Half-Life (t1/2) 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(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(Baseline up to Day 30)
Maximum Observed Plasma Concentration (Cmax) 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 JNJ-26366821 Concentration Versus Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) 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)
Time to Reach the Maximum Observed Plasma Concentration (Tmax) 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)