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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-26366821

Study type: Interventional

Funder types: Industry

Identifiers

NCT03990519

26366821RSS1001 (Other Identifier)

CR108637

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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33 participants in 3 patient groups

Cohort1: JNJ-2636682/Placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-26366821

Drug: Placebo

Cohort 2: JNJ-26366821/Placebo

Experimental group

Description:

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

Treatment:

Drug: JNJ-26366821

Drug: Placebo

Cohort 3: JNJ-26366821/Placebo

Experimental group

Description:

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.

Treatment:

Drug: JNJ-26366821

Drug: Placebo