A Study of JNJ-77474462 in Healthy Participants
- Registration Number
- NCT04544813
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort B: JNJ-77474462 SC (Wave 1) JNJ-77474462 Participants will receive single dose of JNJ-77474462 SC. Cohort A: JNJ-77474462 SC (Wave 1) JNJ-77474462 Participants will receive single dose of JNJ-77474462 subcutaneously (SC). Cohort C: JNJ-77474462 SC (Wave 1) JNJ-77474462 Participants will receive single dose of JNJ-77474462 SC. Cohort F: JNJ-77474462 SC (Wave 2) JNJ-77474462 Participants will receive single dose of JNJ-77474462 SC. Cohort G: JNJ-77474462 SC (Wave 2) JNJ-77474462 Participants will receive single dose of JNJ-77474462 SC. Cohort H: JNJ-77474462 IV (Wave 2) JNJ-77474462 Participants will receive single dose of JNJ-77474462 IV. Cohort I: JNJ-77474462 IV (Wave 2) JNJ-77474462 Participants will receive single dose of JNJ-77474462 IV. Cohort E: JNJ-77474462 IV (Wave 1) JNJ-77474462 Participants will receive single dose of JNJ-77474462 intravenously (IV). Cohort D: JNJ-77474462 SC (Wave 1) JNJ-77474462 Participants will receive single dose of JNJ-77474462 SC. Cohort J: Anakinra SC Anakinra Participants will receive a SC injection of anakinra once daily for 3 days.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462 Up to Week 12 Cmax is the maximum observed plasma concentration.
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.
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 (%).
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
Nucleus Network, Q-Pharm Pty Ltd
🇦🇺Herston, Australia