HealthyPhase 1NCT05407818
A Study of JNJ-63733657 in Healthy Chinese Participants
A Phase 1 study testing JNJ-63733657 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-63733657
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2022to 7 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- JNJ-63733657
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-63733657Drug
JNJ-63733657 will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-63733657 | Experimental | Participants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1. Receives: Drug: JNJ-63733657 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Concentrations of JNJ-63733657
Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.
Measured: Up to Week 13
Secondary outcomes (7)
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.
Measured: Up to Week 13
Percentage of Participants with Discontinuations due to AEs
Percentage of participants with discontinuations due to AEs will be reported.
Measured: Up to Week 17
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.
Measured: Up to Week 17
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.
Measured: Up to Week 17
Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
Percentage of participants with clinically significant changes in ECGs will be reported.
Measured: Up to Week 17
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.
Measured: Up to Week 17
Percentage of Participants with Anti-drug Antibodies to JNJ-63733657
Percentage of participants with anti-drug antibodies to JNJ-63733657 will be reported.
Measured: Up to Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start27 Jun 2022
- Primary completion2 Aug 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407818
- Sponsor's protocol ID
- CR109144
- Other IDs
- 63733657ALZ1001
- Status last verified
- Apr 2025
- First submitted
- 2 Jun 2022
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT05407818
- Acronym / sponsor ID
- CR109144
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-63733657 | Experimental | Drug: JNJ-63733657Participants will receive a single dose of JNJ-63733657 as an intravenous (IV) infusion on Day 1. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-63733657JNJ-63733657 will be administered as an IV infusion. | Drug | JNJ-63733657 |
Primary outcome
Serum Concentrations of JNJ-63733657
Time frame: Up to Week 13
Serum samples will be analyzed to determine concentrations of JNJ-63733657 using a validated, specific, and sensitive Immunoassay method.
7 secondary outcomes
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Time frame: Up to Week 13
Percentage of Participants with Discontinuations due to AEs
Time frame: Up to Week 17
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 17
Percentage of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Week 17
Percentage of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
Time frame: Up to Week 17
Percentage of Participants with Clinically Significant Changes in Clinical Safety Laboratory Parameters
Time frame: Up to Week 17
Percentage of Participants with Anti-drug Antibodies to JNJ-63733657
Time frame: Up to Week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-63733657 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Concentrations of JNJ-63733657 (time frame: Up to Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.