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

NCT ID: NCT03990519

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2020-02-19

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cohort1: JNJ-2636682/Placebo

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

Group Type: EXPERIMENTAL

JNJ-26366821

Intervention Type: DRUG

Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Placebo

Intervention Type: DRUG

Participants will receive sodium chloride injection as placebo on Day 1.

Cohort 2: JNJ-26366821/Placebo

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

Group Type: EXPERIMENTAL

JNJ-26366821

Intervention Type: DRUG

Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Placebo

Intervention Type: DRUG

Participants will receive sodium chloride injection as placebo on Day 1.

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.

Group Type: EXPERIMENTAL

JNJ-26366821

Intervention Type: DRUG

Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Placebo

Intervention Type: DRUG

Participants will receive sodium chloride injection as placebo on Day 1.

Interventions

JNJ-26366821

Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Intervention Type: DRUG

Placebo

Participants will receive sodium chloride injection as placebo on Day 1.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Harbor Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

26366821RSS1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR108637

Identifier Type: -

Identifier Source: org_study_id