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Completed

NCT Number: NCT03990519

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

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Harbor Hospital

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-26366821

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-26366821

    Time frame: 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.

  2. Area Under the Plasma Concentration Versus Time Curve from Time 0 to Time of the Last Measurable Concentration AUC0-Last of JNJ-26366821

    Time frame: 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.

  3. Apparent Elimination Half-Life (t1/2) of JNJ-26366821

    Time frame: 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.

  4. Area Under the JNJ-26366821 Concentration Versus Time Curve from Time 0 to Infinite Time (AUC[0-infinity]) of JNJ-26366821

    Time frame: 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.

  5. Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-26366821

    Time frame: 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.

  6. Change in Platelet Count from Baseline at Each Dose and Time

    Time frame: Baseline up to Day 30

    Change from baseline in platelet count at each dose and time will be assessed.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 19, 2019
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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