A Study of JNJ-77474462 in Healthy Participants

Sponsor
Janssen Research & Development, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04544813
Collaborator
(none)
78
1
10
7.5
10.4

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Oct 13, 2020
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462 [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 [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 [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 [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%) [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) [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) [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 [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) [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 [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 [Up to Week 12]

      Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Nucleus Network, Q-Pharm Pty Ltd Herston Australia 4006

    Sponsors and Collaborators

    • Janssen Research & Development, LLC

    Investigators

    • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Janssen Research & Development, LLC
    ClinicalTrials.gov Identifier:
    NCT04544813
    Other Study ID Numbers:
    • CR108771
    • 77474462ADM1001
    First Posted:
    Sep 10, 2020
    Last Update Posted:
    Jul 9, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 9, 2021