HealthyPhase 1NCT05252520

A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants

A Phase 1 study testing JNJ-77474462 in people with Healthy, run by Janssen Research & Development, LLC.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: JNJ-77474462
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 May 2023to 20 Nov 2023
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 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Have a body mass index (BMI) between 18 and 27.9 kilograms per meter square (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of between 50 to 90 kg, inclusive
Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -2 to -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
A female of childbearing potential must have a negative pregnancy test at screening and on Day -2 to -1
Must have 3 quadrants on the abdomen where the skin is not tender, bruised, red, scaly, hardened, or tattooed for subcutaneous (SC) administration
Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

Who cannot join

History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before Screening or positive test result(s) for alcohol or drugs of abuse (including morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, dimethylene dioxoamphetamine, cocaine) at Screening and Day -2 to -1
Have a history of active granulomatous infection (including histoplasmosis or coccidioidomycosis), nontuberculous mycobacterial infection or opportunistic infection (including pneumocystosis, aspergillosis, and disseminated herpes zoster defined as zoster with central nervous system involvement or zoster spreading to more than 2 adjacent dermatomes)
Has a chest radiograph within 3 months before the first administration of study intervention that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB). A chest computerized tomography (CT) scan is also acceptable if already available or obtained outside of the study protocol
Has tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and treponema pallidum-specific antibody

About this study

Official title: A Phase 1 Open-label Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants Following Subcutaneous Administration

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants.

Conditions: Healthy
Being tested: JNJ-77474462

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

JNJ-77474462Drug
Also called Bermekimab
JNJ-77474462 will be administered subcutaneously.

Study groups in NCT05252520
Study group	Role	What they receive
JNJ-77474462	Experimental	Participants will receive a single subcutaneous (SC) Dose 1 of JNJ-77474462 on Day 1 in Cohort 1, a single SC Dose 2 of JNJ-77474462 on Day 1 in Cohort 2 and a single SC Dose 3 of JNJ-77474462 on Day 1 in Cohort 3. Receives: Drug: JNJ-77474462

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Concentration (Cmax) of JNJ-77474462
Cmax is defined as the maximum observed serum concentration of JNJ-77474462.
Measured: Up to Day 85
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462
Tmax is defined as the time to reach maximum observed serum concentration of JNJ-77474462.
Measured: Up to Day 85
Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462
AUC (0-infinity) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to infinity with extrapolation of the terminal phase.
Measured: Up to Day 85
Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC [0-Last]) of JNJ-77474462
AUC (0-Last) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Measured: Up to Day 85
Terminal Half-life (T1/2) of JNJ-77474462
T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462.
Measured: Up to Day 85
Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462
CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462.
Measured: Up to Day 85
Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462
Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462.
Measured: Up to Day 85

Secondary outcomes (8)

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Percentage of participants with TEAEs by severity will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Any AE occurring at or after the initial administration of study intervention through Day 85 is considered to be treatment-emergent. Severity will be assessed based on the following categories: a) Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities, b) Moderate: Sufficient discomfort is present to cause interference with normal activity and c) Severe: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities.
Measured: Up to Day 85
Percentage of Participants with Serious Adverse Events (SAEs)
Percentage of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported.
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
Number of participants with clinically significant changes in ECGs will be reported.
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Hematology Parameters
Number of participants with clinically significant changes in hematology parameters will be reported.
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Chemistry Parameters
Number of participants with clinically significant changes in chemistry parameters will be reported.
Measured: Up to Day 85
Number of Participants with Clinically Significant Changes in Urinalysis
Number of participants with clinically significant changes in urinalysis will be reported.
Measured: Up to Day 85
Number of Participants with Presence of Antibodies to JNJ-77474462
Number of participants with presence of antibodies to JNJ-77474462 will be reported. The detection and characterization of antibodies to JNJ-77474462 will be performed using a validated drug-tolerant method.
Measured: Up to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202320 Nov 2023

First posted23 Feb 2022
Study start1 May 2023 (estimated)
Primary completion20 Nov 2023 (estimated)
Study completion20 Nov 2023 (estimated)

Why it stopped: The development of bermekimab in Immunology is stopped

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: Sequential
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05252520
Sponsor's protocol ID: CR109109
Other IDs: 77474462HDS1001
Status last verified: Jan 2025
First submitted: 16 Feb 2022
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-label Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants Following Subcutaneous Administration
ClinicalTrials.gov ID: NCT05252520
Acronym / sponsor ID: CR109109
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The development of bermekimab in Immunology is stopped
Enrolment: 0 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 1 May 2023 (estimated)
Primary completion: 20 Nov 2023 (estimated)
Study completion: 20 Nov 2023 (estimated)
First posted: 23 Feb 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-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
JNJ-77474462	Experimental	Drug: JNJ-77474462Participants will receive a single subcutaneous (SC) Dose 1 of JNJ-77474462 on Day 1 in Cohort 1, a single SC Dose 2 of JNJ-77474462 on Day 1 in Cohort 2 and a single SC Dose 3 of JNJ-77474462 on Day 1 in Cohort 3.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Have a body mass index (BMI) between 18 and 27.9 kilograms per meter square (kg/m^2) (BMI = weight/height^2), inclusive, and a body weight of between 50 to 90 kg, inclusive
Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -2 to -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
A female of childbearing potential must have a negative pregnancy test at screening and on Day -2 to -1
Must have 3 quadrants on the abdomen where the skin is not tender, bruised, red, scaly, hardened, or tattooed for subcutaneous (SC) administration
Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

Key exclusion criteria (5 listed)

History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before Screening or positive test result(s) for alcohol or drugs of abuse (including morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, dimethylene dioxoamphetamine, cocaine) at Screening and Day -2 to -1
Have a history of active granulomatous infection (including histoplasmosis or coccidioidomycosis), nontuberculous mycobacterial infection or opportunistic infection (including pneumocystosis, aspergillosis, and disseminated herpes zoster defined as zoster with central nervous system involvement or zoster spreading to more than 2 adjacent dermatomes)
Has a chest radiograph within 3 months before the first administration of study intervention that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB). A chest computerized tomography (CT) scan is also acceptable if already available or obtained outside of the study protocol
Has tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and treponema pallidum-specific antibody

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-77474462Also: BermekimabJNJ-77474462 will be administered subcutaneously.	Drug	JNJ-77474462

Primary outcome

Maximum Observed Serum Concentration (Cmax) of JNJ-77474462
Time frame: Up to Day 85
Cmax is defined as the maximum observed serum concentration of JNJ-77474462.
Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462
Time frame: Up to Day 85
Tmax is defined as the time to reach maximum observed serum concentration of JNJ-77474462.
Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462
Time frame: Up to Day 85
AUC (0-infinity) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to infinity with extrapolation of the terminal phase.
Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC [0-Last]) of JNJ-77474462
Time frame: Up to Day 85
AUC (0-Last) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Terminal Half-life (T1/2) of JNJ-77474462
Time frame: Up to Day 85
T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462.
Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462
Time frame: Up to Day 85
CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462.
Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462
Time frame: Up to Day 85
Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462.

8 secondary outcomes

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
Time frame: Up to Day 85
Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Hematology Parameters
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Chemistry Parameters
Time frame: Up to Day 85
Number of Participants with Clinically Significant Changes in Urinalysis
Time frame: Up to Day 85
Number of Participants with Presence of Antibodies to JNJ-77474462
Time frame: Up to Day 85

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-77474462 in people with Healthy, run by Janssen Research & Development, LLC.

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: withdrawn, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Maximum Observed Serum Concentration (Cmax) of JNJ-77474462 (time frame: Up to Day 85). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05252520.

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 3 Feb 2025.