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Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12624001368527
Ethics application status
Approved
Date submitted
11/10/2024
Date registered
15/11/2024
Date last updated
24/11/2024
Date data sharing statement initially provided
15/11/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
A Single Ascending Dose/Optional Multiple Ascending Dose Study of JNJ-95597528 in Healthy Participants
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Scientific title
Phase 1, Randomized, Double-Blind, Placebo Controlled, First-In-Human Single Ascending Dose
Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of JNJ95597528 and a Proof of Mechanism Study in Participants with Mild to Moderate Asthma: Part A Single Ascending Dose and Optional Multiple Ascending Dose Study
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Secondary ID [1]
313167
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2024-517644-62-00
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
335451
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Condition category
Condition code
Inflammatory and Immune System
332009
332009
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0
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Autoimmune diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Arms:
Arm 1 - Single Ascending Dose (SAD) Cohort; Type: Experimental; Description: Healthy participants will receive a single dose of JNJ-95597528 or placebo through subcutaneous (SC) administration on Day 1. The first 3 SAD cohorts (SAD1, SAD2, SAD3) are required cohorts and the last 4 SAD cohorts (SAD4, SAD5, SAD6, SAD7) are optional cohorts.
Arm 2 - Optional Multiple Ascending Dose (MAD) Cohort; Type: Experimental; Description: Healthy participants will be enrolled into 1 to 2 cohorts in the MAD part and will receive 1 SC injection once a week for total of 3 SC injections of JNJ-95597528 or placebo starting on Day 1.
Intervention name: JNJ-95597528 - Drug
Associated arms: Single Ascending Dose (SAD) Cohort; and Optional Multiple Ascending Dose (MAD) Cohort
JNJ-95597528 will be administered at a dose decided by data safety monitoring board (DSMB) equivalent starting from 100 mg up to a maximum cumulative dose of 1800 mg for SAD and MAD Cohorts. The dose will be escalated only if the safety and tolerability profiles are deemed acceptable as determined by safety data generated from SAD cohorts. It will be administered by medical professionals including registered nurses through subcutaneous injection. No monitoring adherence will be performed.
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Intervention code [1]
329739
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Treatment: Drugs
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Comparator / control treatment
Intervention name: Placebo - Drug
Associated arms: Single Ascending Dose (SAD) Cohort; and Optional Multiple Ascending Dose
(MAD) Cohort
Placebo composed of the formulation buffer (His buffer, sucrose, arginine-HCl, and PS80) of the study intervention will be administered subcutaneously.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
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Assessment method [1]
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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 (For example [e.g.], systemic hypersensitivity reactions, infections including parasitic infections, conjunctivitis, keratitis etc.). TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment (for e.g. spirometry risk, acute asthma exacerbation). Severity of AEs will be assessed using general categorical descriptors: Mild (Symptoms that are easily tolerated, cause minimal discomfort, and don't interfere with everyday activities), Moderate (sufficient discomfort present to cause interference with normal activities) and Severe (extreme distress, causing significant impairment of functioning or incapacitation preventing normal everyday activities). AEs will be reported by participants and will be monitored using site staff assessments, physical exam, blood tests, vital signs monitoring and Electrocardiograms (ECGs) etc.
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Timepoint [1]
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From the beginning of the screening period until the end of the study (SAD: Predose, Week 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Week 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67)
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Primary outcome [2]
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Number of Participants with Treatment-Emergent Serious Adverse Events (SAEs)
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Assessment method [2]
339611
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SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires hospitalization or prolonging 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 and is medically important (for e.g. systemic hypersensitivity reactions). SAEs will be reported by participants and will be monitored using site staff assessments, physical exam, blood tests, vital signs monitoring and ECGs etc.
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Timepoint [2]
339611
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From the beginning of the screening period until the end of the study (SAD: Predose, Week 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Week 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67)
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Primary outcome [3]
339612
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Number of Participants With Clinically Significant Abnormalities Assessed as a Composite of Parameters Including Vital Signs, Physical Examination, Laboratory Parameters and Electrocardiogram (ECG)
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Assessment method [3]
339612
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Participants with clinically significant vital sign abnormalities (temperature [oral, tympanic] using thermometer, pulse/heart rate, respiratory rate, blood pressure, and oxygen saturation using pulse oximeter), physical examinations (general and targeted), laboratory parameters (serum chemistry and hematology using blood samples collected at specified timepoints) and abnormalities in 12-lead ECG readings using relevant device will be reported. This will be assessed as a composite outcome measure.
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Timepoint [3]
339612
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From the beginning of the screening period until the end of the study (SAD: Predose, Week 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Week 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67)
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Secondary outcome [1]
440579
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Serum Concentration for JNJ-95597528
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Assessment method [1]
440579
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Blood samples will be collected at different time points for measurement of serum concentrations of JNJ-95597528.
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Timepoint [1]
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [2]
440580
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Maximum Concentration after Last Dose (Cmax) for JNJ-95597528
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Assessment method [2]
440580
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Blood (serum) samples will be analyzed to determine Cmax of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [2]
440580
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [3]
440581
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Time to Reach Cmax (tmax) for JNJ-95597528
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Assessment method [3]
440581
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Blood (serum) samples will be analyzed to determine Tmax of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [3]
440581
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [4]
440582
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Area Under the Serum Concentration-Time Curve from Time 0 to 24 Hours Post dose (AUC0-24h) for JNJ-95597528
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Assessment method [4]
440582
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Blood (serum) samples will be analyzed to determine AUC0-24h of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [4]
440582
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Week 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [5]
440583
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Area Under the Serum Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) for JNJ-9559758
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Assessment method [5]
440583
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Blood (serum) samples will be analyzed to determine AUClast of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [5]
440583
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [6]
440584
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Area Under the Serum Concentration-Time Curve from Time 0 to Infinite Time (AUC0-infinite) for JNJ-95597528
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Assessment method [6]
440584
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Blood (serum) samples will be analyzed to determine AUC0-infinite of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [6]
440584
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [7]
440585
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Total Apparent Oral Clearance (CL/F) for JNJ-95597528
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Assessment method [7]
440585
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Blood (serum) samples will be analyzed to determine CL/F of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [7]
440585
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [8]
440586
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Apparent Volume of Distribution (Vd/F) for JNJ-95597528
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Assessment method [8]
440586
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Blood (serum) samples will be analyzed to determine Vd/F of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [8]
440586
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [9]
440587
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Apparent Elimination Half-life (t1/2) for JNJ-95597528
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Assessment method [9]
440587
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Blood (serum) samples will be analyzed to determine t1/2 of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [9]
440587
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [10]
440588
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Apparent Terminal Elimination Rate-Constant (Lambda-z) for JNJ-95597528
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Assessment method [10]
440588
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Blood (serum) samples will be analyzed to determine Lambda-z of JNJ-95597528 using a validated, specific, and sensitive immunoassay method or under the supervision of the Sponsor.
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Timepoint [10]
440588
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Secondary outcome [11]
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Number of Participants with Anti-Drug Antibodies to JNJ-95597528
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Assessment method [11]
440589
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Antibodies to JNJ-95597528 will be evaluated in serum samples using a validated assay method.
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Timepoint [11]
440589
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SAD: Predose, Weeks 1, 2, 3, 5, 7, 9, 13, 25, 37, 47 and 65; Optional MAD: Predose, Weeks 1, 2, 3, 4, 5, 7, 9, 11, 15, 27, 39, 49 and 67
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Eligibility
Key inclusion criteria
- Healthy on the basis of physical examination, medical history, vital signs,12-lead ECG and clinical laboratory tests performed at screening
- Body mass index (BMI) between 18 and 32 kilogram/meter square (kg/m^2), and a body weight of no less than 50 kg
- All females must have a negative highly sensitive serum beta-hCG at screening and a negative urine pregnancy test on Day -1 and agree to further pregnancy tests
- Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- History of chronic liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Have an active, acute or chronic infection
- Has or had a serious infection (for example [e.g.], sepsis, pneumonia or pyelonephritis) or has been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to screening
- Has or has had a helminth infection that has not been documented resolved by the treating physician
- Has or has had an acute illness, including a common cold, within 2 weeks prior to study intervention administration
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
5/12/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
76
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Research & Development, LLC
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
319922
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Address [1]
319922
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Country [1]
319922
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316314
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
316314
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
316314
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Australia
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Date submitted for ethics approval [1]
316314
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02/10/2024
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Approval date [1]
316314
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29/10/2024
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Ethics approval number [1]
316314
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HREC/112699-Alfred-2024
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Summary
Brief summary
The purpose of this study is to evaluate the safety and tolerability of JNJ-95597528 after single and optional multiple ascending dose administration in healthy participants.
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Trial website
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Trial related presentations / publications
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Public notes
Also part of the Inclusion Criteria: - Have a negative coronavirus disease 2019 (COVID19) polymerase chain reaction (PCR) test result prior to administration of study intervention - Have a negative COVID-19 PCR test result prior to administration of study intervention
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Contacts
Principal investigator
Name
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Dr Phillip Ryan
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Address
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Nucleus Network Pty Ltd, 89 Commercial Road, Melbourne, VIC, 3004
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Country
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Australia
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Phone
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+61 438 009 787
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Fax
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Email
137494
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[email protected]
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Contact person for public queries
Name
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Lewis Tan
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Address
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Nucleus Network Pty Ltd, Level 3/549 St Kilda Rd Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 3 8593 9801
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Fax
137495
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Email
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[email protected]
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Contact person for scientific queries
Name
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Phillip Ryan
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Address
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Nucleus Network Pty Ltd, 89 Commercial Road, Melbourne, VIC, 3004
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Country
137496
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Australia
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Phone
137496
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+61 438 009 787
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Fax
137496
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Email
137496
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose
Conditions for requesting access:
•
-
What individual participant data might be shared?
•
All of the individual participant data collected during the trial, after de-identification
What types of analyses could be done with individual participant data?
•
To achieve aims in the approved proposal
When can requests for individual participant data be made (start and end dates)?
From:
Beginning 18 months after last patient, last visit and EU and US approvals. No end date.
To:
-
Where can requests to access individual participant data be made, or data be obtained directly?
•
Proposals should be directed to https://yoda.yale.edu/. To gain access, once the proposal is approved, data requestors will need to sign a data access agreement. Data are available for 1- year (extendable by agreed extension) thorough the YODA Project process.
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF