- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05407818
A Study of JNJ-63733657 in Healthy Chinese Participants
December 7, 2023 updated by: Janssen Research & Development, LLC
A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese Participants
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100089
- Peking University Third Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: JNJ-63733657
Participants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1.
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JNJ-63733657 will be administered as an IV infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Concentrations of JNJ-63733657
Time Frame: Up to Week 13
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Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.
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Up to Week 13
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Time Frame: Up to Week 13
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product.
An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
An assessment of severity grade will be made using the following general categorical descriptors: Mild, Moderate, and Severe.
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Up to Week 13
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Percentage of Participants with Discontinuations due to AEs
Time Frame: Up to Week 17
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Percentage of participants with discontinuations due to AEs will be reported.
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Up to Week 17
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Percentage of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Week 17
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An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
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Up to Week 17
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Percentage of Participants with Clinically Significant Changes in Vital Signs
Time Frame: Up to Week 17
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Percentage of participants with clinically significant changes in vital signs (including temperature [axillary], pulse/heart rate, respiratory rate, and blood pressure) will be reported.
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Up to Week 17
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Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
Time Frame: Up to Week 17
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Percentage of participants with clinically significant changes in ECGs will be reported.
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Up to Week 17
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Percentage of Participants with Clinically Significant Changes in Clinical Safety Laboratory Parameters
Time Frame: Up to Week 17
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Percentage of participants with clinically significant changes in clinical safety laboratory parameters (including hematology, chemistry, and urinalyses) will be reported.
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Up to Week 17
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Percentage of Participants with Anti-drug Antibodies to JNJ-63733657
Time Frame: Up to Week 13
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Percentage of participants with anti-drug antibodies to JNJ-63733657 will be reported.
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Up to Week 13
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2022
Primary Completion (Actual)
August 2, 2022
Study Completion (Actual)
November 7, 2022
Study Registration Dates
First Submitted
June 2, 2022
First Submitted That Met QC Criteria
June 2, 2022
First Posted (Actual)
June 7, 2022
Study Record Updates
Last Update Posted (Estimated)
December 11, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CR109144
- 63733657ALZ1001 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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