HealthyPhase 1NCT04544813
A Study of JNJ-77474462 in Healthy Participants
A Phase 1 study testing JNJ-77474462 and Anakinra in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Australia.
Trial summary
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy 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 and Anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Oct 2020to 30 May 2021
- 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
- Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. 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
- Otherwise healthy on the basis of clinical laboratory tests performed at screening and Day 1. If the results of the serum chemistry panel, 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta hCG) at screening and a negative urine pregnancy test on Day -1
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days post study intervention administration
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention
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, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Has or has had a serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to the screening visit
- Is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
- Has received prescription medications within 2 weeks prior to first study intervention administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.
- Conditions
- Healthy
- Being tested
- JNJ-77474462, Anakinra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-77474462Drug
Also called Bermekimab
Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
AnakinraDrug
Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 subcutaneously (SC). Receives: Drug: JNJ-77474462 |
| Cohort B: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 SC. Receives: Drug: JNJ-77474462 |
| Cohort C: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 SC. Receives: Drug: JNJ-77474462 |
| Cohort D: JNJ-77474462 SC (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 SC. Receives: Drug: JNJ-77474462 |
| Cohort E: JNJ-77474462 IV (Wave 1) | Experimental | Participants will receive single dose of JNJ-77474462 intravenously (IV). Receives: Drug: JNJ-77474462 |
| Cohort F: JNJ-77474462 SC (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 SC. Receives: Drug: JNJ-77474462 |
| Cohort G: JNJ-77474462 SC (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 SC. Receives: Drug: JNJ-77474462 |
| Cohort H: JNJ-77474462 IV (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 IV. Receives: Drug: JNJ-77474462 |
| Cohort I: JNJ-77474462 IV (Wave 2) | Experimental | Participants will receive single dose of JNJ-77474462 IV. Receives: Drug: JNJ-77474462 |
| Cohort J: Anakinra SC | Active comparator | Participants will receive a SC injection of anakinra once daily for 3 days. Receives: Drug: Anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
Cmax is the maximum observed plasma concentration.
Measured: Up to Week 12
Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462
AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
Measured: Up to Week 12
Area Under the Plasma 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 area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
Measured: Up to Week 12
Terminal Half-Life (T1/2) of JNJ-77474462
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
Measured: Up to Week 12
Absolute Subcutaneous (SC) Bioavailability (F%)
(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV * 100 percent (%).
Measured: Up to Week 12
Secondary outcomes (6)
Percentage of Participants with Treatment-emergent Adverse Events (TEAE)
An 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. TEAEs are defined as adverse events (AEs) with onset or worsening on or after date of first dose of study treatment.
Measured: Up to Week 12
Percentage of Participants with Serious Adverse Events (SAE)
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to Week 12
Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs (including body temperature, resting [supine] pulse/heart rate, respiratory rate and blood pressure) will be reported.
Measured: Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)
Number of participants with clinically significant changes ECG will be reported.
Measured: Up to Week 12
Number of Participants with Clinically Significant Changes in Laboratory Findings
Number of participants with clinically significant changes in laboratory findings (that is, hematology, clinical chemistry, urinalysis) will be reported.
Measured: Up to Week 12
Number of Participants with Anti-JNJ-77474462 Antibodies
Number of participants with anti-drug antibodies to JNJ-77474462 will be reported.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start13 Oct 2020
- Primary completion30 May 2021
- Study completion30 May 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT04544813
- Sponsor's protocol ID
- CR108771
- Other IDs
- 77474462ADM1001
- Status last verified
- Jun 2023
- First submitted
- 9 Sep 2020
- Last updated
- 29 Jun 2023
- 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 \& 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 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04544813
- Acronym / sponsor ID
- CR108771
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 10 Sep 2020 (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 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort A: JNJ-77474462 SC (Wave 1) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 subcutaneously (SC). |
| Cohort B: JNJ-77474462 SC (Wave 1) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 SC. |
| Cohort C: JNJ-77474462 SC (Wave 1) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 SC. |
| Cohort D: JNJ-77474462 SC (Wave 1) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 SC. |
| Cohort E: JNJ-77474462 IV (Wave 1) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 intravenously (IV). |
| Cohort F: JNJ-77474462 SC (Wave 2) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 SC. |
| Cohort G: JNJ-77474462 SC (Wave 2) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 SC. |
| Cohort H: JNJ-77474462 IV (Wave 2) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 IV. |
| Cohort I: JNJ-77474462 IV (Wave 2) | Experimental | Drug: JNJ-77474462Participants will receive single dose of JNJ-77474462 IV. |
| Cohort J: Anakinra SC | Active comparator | Drug: AnakinraParticipants will receive a SC injection of anakinra once daily for 3 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. 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
- Otherwise healthy on the basis of clinical laboratory tests performed at screening and Day 1. If the results of the serum chemistry panel, 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 or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta hCG) at screening and a negative urine pregnancy test on Day -1
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days post study intervention administration
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention
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, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Has or has had a serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to the screening visit
- Is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
- Has received prescription medications within 2 weeks prior to first study intervention administration
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: BermekimabParticipants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion). | Drug | Cohort A: JNJ-77474462 SC (Wave 1), Cohort B: JNJ-77474462 SC (Wave 1), Cohort C: JNJ-77474462 SC (Wave 1), Cohort D: JNJ-77474462 SC (Wave 1), Cohort E: JNJ-77474462 IV (Wave 1), Cohort F: JNJ-77474462 SC (Wave 2), Cohort G: JNJ-77474462 SC (Wave 2), Cohort H: JNJ-77474462 IV (Wave 2), Cohort I: JNJ-77474462 IV (Wave 2) |
| AnakinraParticipants will receive a SC injection of anakinra 100 mg once daily for 3 days. | Drug | Cohort J: Anakinra SC |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
Time frame: Up to Week 12
Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462
Time frame: Up to Week 12
AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
Area Under the Plasma 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 Week 12
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
Terminal Half-Life (T1/2) of JNJ-77474462
Time frame: Up to Week 12
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
Absolute Subcutaneous (SC) Bioavailability (F%)
Time frame: Up to Week 12
(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV * 100 percent (%).
6 secondary outcomes
Percentage of Participants with Treatment-emergent Adverse Events (TEAE)
Time frame: Up to Week 12
Percentage of Participants with Serious Adverse Events (SAE)
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)
Time frame: Up to Week 12
Number of Participants with Clinically Significant Changes in Laboratory Findings
Time frame: Up to Week 12
Number of Participants with Anti-JNJ-77474462 Antibodies
Time frame: Up to Week 12
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 29 Jun 2023.
- 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-77474462 and Anakinra in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Australia.
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 29 Jun 2023. 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 Australia. 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?
Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462 (time frame: Up to Week 12). The study lists 5 primary outcomes in all. 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 29 Jun 2023.