Clinical trial NCT05407818: A Study of JNJ-63733657 in Healthy Chinese Participants
Official title: A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Healthy for their age group on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiograms (ECGs) performed at screening. If there are any abnormalities, they must be considered not clinically relevant and this determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy for their age group on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, 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. This determination must be recorded in the participant's source documents and initialed by the investigator
* Body mass index (BMI) between 18 and 35 kilograms per meter square (kg/m\^2) (inclusive), and body weight greater than 50 kilograms (kg) but less than 80 kg (in order not to exceed the total dose of 5 grams \[g\] JNJ-63733657) at screening
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 150 millimeters of mercury (mm Hg) systolic, inclusive, and no higher than 90 mm Hg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted. The participant will be considered eligible if any one of the blood pressure assessments within the range of 90-150 systolic and less than 90 diastolic
* Willing and able to adhere to the prohibitions and restrictions specified in the protocol

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Known allergies, hypersensitivity, or suspected intolerance to any biologic medication or known allergies, or clinically significant reactions to human proteins, monoclonal antibodies or antibody fragments, JNJ-63733657 or its excipients
* Taken any disallowed therapies, concomitant therapy before the planned administration of study intervention. The use of medication that is considered not to have any impact on the study results may be allowed after agreement between the investigator and the sponsor's medical monitor
* Received an investigational drug (including vaccines) or used an experimental medical device within 3 months or within a period less than 5 times the drug's half-life, if known, whichever is longer, before the administration of study intervention
* Preplanned surgery or procedures that would interfere with the conduct of the study

Primary outcomes:
measure: Serum Concentrations of JNJ-63733657
timeFrame: Up to Week 13
Secondary outcomes:
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
timeFrame: Up to Week 13
measure: Percentage of Participants with Discontinuations due to AEs
timeFrame: Up to Week 17
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Week 17
measure: Percentage of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Week 17
measure: Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
timeFrame: Up to Week 17
measure: Percentage of Participants with Clinically Significant Changes in Clinical Safety Laboratory Parameters
timeFrame: Up to Week 17
measure: Percentage of Participants with Anti-drug Antibodies to JNJ-63733657
timeFrame: Up to Week 13
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: