A Study of JNJ-63733657 in Healthy Chinese Participants

Healthy Clinical Trial

Official title:

A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05407818
• Other study ID #: CR109144
• Secondary ID: 63733657ALZ1001
• Status: Completed
• Phase: Phase 1
• Start date: June 27, 2022
• Est. completion date: November 7, 2022

Study information

• Verified date: December 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-63733657 following single intravenous (IV) dose administration in healthy Chinese participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 7, 2022
• Est. primary completion date: August 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-63733657
JNJ-63733657 will be administered as an IV infusion.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Concentrations of JNJ-63733657	Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.	Up to Week 13
Secondary	Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity	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.	Up to Week 13
Secondary	Percentage of Participants with Discontinuations due to AEs	Percentage of participants with discontinuations due to AEs will be reported.	Up to Week 17
Secondary	Percentage of Participants with Serious Adverse Events (SAEs)	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.	Up to Week 17
Secondary	Percentage of Participants with Clinically Significant Changes in Vital Signs	Percentage of participants with clinically significant changes in vital signs (including temperature [axillary], pulse/heart rate, respiratory rate, and blood pressure) will be reported.	Up to Week 17
Secondary	Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)	Percentage of participants with clinically significant changes in ECGs will be reported.	Up to Week 17
Secondary	Percentage of Participants with Clinically Significant Changes in Clinical Safety Laboratory Parameters	Percentage of participants with clinically significant changes in clinical safety laboratory parameters (including hematology, chemistry, and urinalyses) will be reported.	Up to Week 17
Secondary	Percentage of Participants with Anti-drug Antibodies to JNJ-63733657	Percentage of participants with anti-drug antibodies to JNJ-63733657 will be reported.	Up to Week 13