Clinical trial NCT03990519: A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-06-19
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
timeFrame: Up to Day 30
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-26366821
timeFrame: 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
measure: Area Under the Plasma Concentration Versus Time Curve from Time 0 to Time of the Last Measurable Concentration AUC0-Last of JNJ-26366821
timeFrame: 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
measure: Apparent Elimination Half-Life (t1/2) of JNJ-26366821
timeFrame: 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
measure: Area Under the JNJ-26366821 Concentration Versus Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-26366821
timeFrame: 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
measure: Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-26366821
timeFrame: 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
measure: Change in Platelet Count from Baseline at Each Dose and Time
timeFrame: Baseline up to Day 30
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Harbor Hospital
state: Maryland
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: