Clinical trial NCT04544813: A Study of JNJ-77474462 in Healthy Participants
Official title: A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
timeFrame: Up to Week 12
measure: 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
timeFrame: Up to Week 12
measure: 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
timeFrame: Up to Week 12
measure: Terminal Half-Life (T1/2) of JNJ-77474462
timeFrame: Up to Week 12
measure: Absolute Subcutaneous (SC) Bioavailability (F%)
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAE)
timeFrame: Up to Week 12
measure: Percentage of Participants with Serious Adverse Events (SAE)
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)
timeFrame: Up to Week 12
measure: Number of Participants with Clinically Significant Changes in Laboratory Findings
timeFrame: Up to Week 12
measure: Number of Participants with Anti-JNJ-77474462 Antibodies
timeFrame: Up to Week 12
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Nucleus Network, Q-Pharm Pty Ltd
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: