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

NCT03990519 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10863726366821RSS1001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to Day 30

Secondary Outcomes (6)

• 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 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

• 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 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

Study Arms (3)

Cohort1: JNJ-2636682/Placebo

EXPERIMENTAL

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

Drug: JNJ-26366821; Drug: Placebo

Cohort 2: JNJ-26366821/Placebo

EXPERIMENTAL

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

Drug: JNJ-26366821; Drug: Placebo

Cohort 3: JNJ-26366821/Placebo

EXPERIMENTAL

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.

Drug: JNJ-26366821; Drug: Placebo

Interventions

JNJ-26366821 DRUG

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

Cohort 2: JNJ-26366821/Placebo; Cohort 3: JNJ-26366821/Placebo; Cohort1: JNJ-2636682/Placebo

Placebo DRUG

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

Cohort 2: JNJ-26366821/Placebo; Cohort 3: JNJ-26366821/Placebo; Cohort1: JNJ-2636682/Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Harbor Hospital

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

RWJ 800088

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: June 24, 2019
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)