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出境医 / 临床实验 / A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants

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

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

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-26366821 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 24, 2019
Actual Primary Completion Date : February 19, 2020
Actual Study Completion Date : February 19, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Cohort1: JNJ-2636682/Placebo
Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
 Drug: JNJ-26366821
Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Drug: Placebo
Participants will receive sodium chloride injection as placebo on Day 1.
Experimental: Cohort 2: JNJ-26366821/Placebo
Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
 Drug: JNJ-26366821
Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Drug: Placebo
Participants will receive sodium chloride injection as placebo on Day 1.
Experimental: 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.
 Drug: JNJ-26366821
Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).

Drug: Placebo
Participants will receive sodium chloride injection as placebo on Day 1.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Locations
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United States, Maryland
Harbor Hospital
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date April 14, 2020
Actual Study Start Date  ICMJE June 24, 2019
Actual Primary Completion Date February 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a Single Subcutaneous Dose of JNJ-26366821 in Healthy Participants
Official Title  ICMJE 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
Brief Summary The purpose of this study is to evaluate the safety and tolerability of a single subcutaneous (SC) dose of JNJ-26366821.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: JNJ-26366821
    Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).
  • Drug: Placebo
    Participants will receive sodium chloride injection as placebo on Day 1.
Study Arms  ICMJE
  • Experimental: Cohort1: JNJ-2636682/Placebo
    Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
    Interventions:
    • Drug: JNJ-26366821
    • Drug: Placebo
  • Experimental: Cohort 2: JNJ-26366821/Placebo
    Participants will receive single dose of JNJ-26366821 or placebo on Day 1.
    Interventions:
    • Drug: JNJ-26366821
    • Drug: Placebo
  • Experimental: 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.
    Interventions:
    • Drug: JNJ-26366821
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2020) 		33
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2019) 		24
Actual Study Completion Date  ICMJE February 19, 2020
Actual Primary Completion Date February 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03990519
Other Study ID Numbers  ICMJE CR108637
26366821RSS1001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
URL: https://www.janssen.com/clinical-trials/transparency
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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