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A Study of JNJ-77474462 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544813
Recruitment Status : Completed
First Posted : September 10, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.

Condition or disease Intervention/treatment Phase
Healthy Drug: JNJ-77474462 Drug: Anakinra Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants
Actual Study Start Date : October 13, 2020
Actual Primary Completion Date : May 30, 2021
Actual Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort A: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 subcutaneously (SC).
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort B: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 SC.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort C: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 SC.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort D: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 SC.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort E: JNJ-77474462 IV (Wave 1)
Participants will receive single dose of JNJ-77474462 intravenously (IV).
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort F: JNJ-77474462 SC (Wave 2)
Participants will receive single dose of JNJ-77474462 SC.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort G: JNJ-77474462 SC (Wave 2)
Participants will receive single dose of JNJ-77474462 SC.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort H: JNJ-77474462 IV (Wave 2)
Participants will receive single dose of JNJ-77474462 IV.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Experimental: Cohort I: JNJ-77474462 IV (Wave 2)
Participants will receive single dose of JNJ-77474462 IV.
 Drug: JNJ-77474462
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
Other Name: Bermekimab
Active Comparator: Cohort J: Anakinra SC
Participants will receive a SC injection of anakinra once daily for 3 days.
 Drug: Anakinra
Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462 [ Time Frame: Up to Week 12 ]
    Cmax is the maximum observed plasma concentration.

  2. Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462 [ Time Frame: Up to Week 12 ]
    AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.

  3. Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC[0-last]) of JNJ-77474462 [ Time Frame: Up to Week 12 ]
    AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.

  4. Terminal Half-Life (T1/2) of JNJ-77474462 [ Time Frame: Up to Week 12 ]
    T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.

  5. Absolute Subcutaneous (SC) Bioavailability (F%) [ Time Frame: Up to Week 12 ]
    (F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV * 100 percent (%).


Secondary Outcome Measures :
  1. Percentage of Participants with Treatment-emergent Adverse Events (TEAE) [ Time Frame: Up to Week 12 ]
    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. TEAEs are defined as adverse events (AEs) with onset or worsening on or after date of first dose of study treatment.

  2. Percentage of Participants with Serious Adverse Events (SAE) [ Time Frame: Up to Week 12 ]
    A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  3. Number of Participants with Clinically Significant Changes in Vital Signs [ Time Frame: Up to Week 12 ]
    Number of participants with clinically significant changes in vital signs (including body temperature, resting [supine] pulse/heart rate, respiratory rate and blood pressure) will be reported.

  4. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) [ Time Frame: Up to Week 12 ]
    Number of participants with clinically significant changes ECG will be reported.

  5. Number of Participants with Clinically Significant Changes in Laboratory Findings [ Time Frame: Up to Week 12 ]
    Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.

  6. Number of Participants with Anti-JNJ-77474462 Antibodies [ Time Frame: Up to Week 12 ]
    Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
  • Otherwise healthy on the basis of clinical laboratory tests performed at screening and Day 1. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
  • A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta hCG) at screening and a negative urine pregnancy test on Day -1
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days post study intervention administration
  • A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention

Exclusion Criteria:

  • History of any clinically significant medical illness or medical 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 history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
  • Has or has had a serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to the screening visit
  • Is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
  • Has received prescription medications within 2 weeks prior to first study intervention administration
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544813


Locations
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Australia
Nucleus Network, Q-Pharm Pty Ltd
Herston, Australia, 4006
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04544813    
Other Study ID Numbers: CR108771
77474462ADM1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents