A Study of JNJ-77474462 in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04544813
• Other study ID #: CR108771
• Secondary ID: 77474462ADM1001
• Status: Completed
• Phase: Phase 1
• Start date: October 13, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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).
• Anakinra
Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.

Locations

Country	Name	City	State
Australia	Nucleus Network, Q-Pharm Pty Ltd	Herston

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462	Cmax is the maximum observed plasma concentration.	Up to Week 12
Primary	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	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.	Up to Week 12
Primary	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	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.	Up to Week 12
Primary	Terminal Half-Life (T1/2) of JNJ-77474462	T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.	Up to Week 12
Primary	Absolute Subcutaneous (SC) Bioavailability (F%)	(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 (%).	Up to Week 12
Secondary	Percentage of Participants with Treatment-emergent Adverse Events (TEAE)	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.	Up to Week 12
Secondary	Percentage of Participants with Serious Adverse Events (SAE)	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.	Up to Week 12
Secondary	Number of Participants with Clinically Significant Changes in Vital Signs	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.	Up to Week 12
Secondary	Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)	Number of participants with clinically significant changes ECG will be reported.	Up to Week 12
Secondary	Number of Participants with Clinically Significant Changes in Laboratory Findings	Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.	Up to Week 12
Secondary	Number of Participants with Anti-JNJ-77474462 Antibodies	Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.	Up to Week 12