Clinical trial NCT04667052: A Study to Compare Two Different Subcutaneously-administered JNJ-64304500 Formulations in Healthy Participants
Official title: An Open-label, Randomized, Parallel Group Study to Assess the Relative Bioavailability of Two Different Subcutaneously-Administered JNJ-64304500 Formulations in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative bioavailability of JNJ-64304500 after administration of two different formulations in healthy participants.


Eligibility criteria: Inclusion criteria:

* Male or non-childbearing potential female (according to their reproductive organs and functions assigned by chromosomal complement)
* For Han Chinese participants, they need to have resided outside of China for no more than 10 years and have parents and maternal and paternal grandparents who are of Han Chinese ethnicity
* Have a body weight in the range of 60 kilograms (kg) to 90 kg and within a body mass index range between 18 and 30 kilogram per square meters (kg/m\^2), inclusive
* Healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening.
* Healthy on the basis of clinical laboratory tests performed at screening.

Exclusion criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to) liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Has a QT corrected according to Fridericia's formula (QTcF) interval greater than (\>) 450 milliseconds (msec) for males, and \>470 msec for females, has a complete left or right bundle branch block, or has a history or current evidence of additional risk factors for torsades de pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome) at screening and at predose (Day -1)
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Had major illness or surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or until Day 113 (Participants who had minor surgical procedures conducted under local anesthesia within 4 weeks before screening may participate)
* Plans to undergo non-major elective surgery within 4 weeks prior to study intervention administration through the end of the study

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of JNJ-64304500
timeFrame: Up to Day 113
measure: Area Under the Serum Concentration - Time Curve From Time Zero to Time Infinity (AUC [0-infinity]) of JNJ-64304500
timeFrame: Up to Day 113
Secondary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 113
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Day 113
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examinations
timeFrame: Up to Day 113
measure: Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to Day 113
measure: Number of Participants with Serum Antibodies to JNJ-64304500
timeFrame: Up to Day 113
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT Global, LLC
state: California
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: