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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-26366821; Drug: Placebo

• Registration Number: NCT03990519
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-19
• Study Start: 2019-06-24
• Primary Completion: 2020-02-19
• Study Completion: 2020-02-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-13
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort1: JNJ-2636682/Placebo	JNJ-26366821	Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
Cohort1: JNJ-2636682/Placebo	Placebo	Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
Cohort 2: JNJ-26366821/Placebo	JNJ-26366821	Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
Cohort 2: JNJ-26366821/Placebo	Placebo	Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
Cohort 3: JNJ-26366821/Placebo	JNJ-26366821	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.
Cohort 3: JNJ-26366821/Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability	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 Outcome Measures

Name	Time	Method
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	T1/2 is define as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.
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	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.
Change in Platelet Count from Baseline at Each Dose and Time	Baseline up to Day 30	Change from baseline in platelet count at each dose and time will be assessed.
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	Cmax is defined as the maximum observed plasma concentration of JNJ- 26366821.
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	AUC (0-infinity) is defined as area under the JNJ-26366821 concentration Versus time curve from Time 0 to infinite time.
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	Tmax is defined as time to reach the maximum observed plasma JNJ-26366821 concentration.

Trial Locations

Locations (1)

Harbor Hospital; 🇺🇸 Baltimore, Maryland, United States