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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
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
Secondary ID [1] 313167 0
2024-517644-62-00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 335451 0
Condition category
Condition code
Inflammatory and Immune System 332009 332009 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 329739 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 339610 0
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
Timepoint [1] 339610 0
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)
Primary outcome [2] 339611 0
Number of Participants with Treatment-Emergent Serious Adverse Events (SAEs)
Timepoint [2] 339611 0
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)
Primary outcome [3] 339612 0
Number of Participants With Clinically Significant Abnormalities Assessed as a Composite of Parameters Including Vital Signs, Physical Examination, Laboratory Parameters and Electrocardiogram (ECG)
Timepoint [3] 339612 0
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)
Secondary outcome [1] 440579 0
Serum Concentration for JNJ-95597528
Timepoint [1] 440579 0
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
Secondary outcome [2] 440580 0
Maximum Concentration after Last Dose (Cmax) for JNJ-95597528
Timepoint [2] 440580 0
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
Secondary outcome [3] 440581 0
Time to Reach Cmax (tmax) for JNJ-95597528
Timepoint [3] 440581 0
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
Secondary outcome [4] 440582 0
Area Under the Serum Concentration-Time Curve from Time 0 to 24 Hours Post dose (AUC0-24h) for JNJ-95597528
Timepoint [4] 440582 0
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
Secondary outcome [5] 440583 0
Area Under the Serum Concentration-Time Curve from Time 0 to Time of the Last Measurable Concentration (AUClast) for JNJ-9559758
Timepoint [5] 440583 0
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
Secondary outcome [6] 440584 0
Area Under the Serum Concentration-Time Curve from Time 0 to Infinite Time (AUC0-infinite) for JNJ-95597528
Timepoint [6] 440584 0
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
Secondary outcome [7] 440585 0
Total Apparent Oral Clearance (CL/F) for JNJ-95597528
Timepoint [7] 440585 0
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
Secondary outcome [8] 440586 0
Apparent Volume of Distribution (Vd/F) for JNJ-95597528
Timepoint [8] 440586 0
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
Secondary outcome [9] 440587 0
Apparent Elimination Half-life (t1/2) for JNJ-95597528
Timepoint [9] 440587 0
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
Secondary outcome [10] 440588 0
Apparent Terminal Elimination Rate-Constant (Lambda-z) for JNJ-95597528
Timepoint [10] 440588 0
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
Secondary outcome [11] 440589 0
Number of Participants with Anti-Drug Antibodies to JNJ-95597528
Timepoint [11] 440589 0
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

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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/12/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317610 0
Commercial sector/Industry
Name [1] 317610 0
Janssen Research & Development, LLC
Country [1] 317610 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
United States of America
Secondary sponsor category [1] 319922 0
None
Name [1] 319922 0
Address [1] 319922 0
Country [1] 319922 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316314 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 316314 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 316314 0
Australia
Date submitted for ethics approval [1] 316314 0
02/10/2024
Approval date [1] 316314 0
29/10/2024
Ethics approval number [1] 316314 0
HREC/112699-Alfred-2024

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.
Trial website
Trial related presentations / publications
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

Contacts
Principal investigator
Name 137494 0
Dr Phillip Ryan
Address 137494 0
Nucleus Network Pty Ltd, 89 Commercial Road, Melbourne, VIC, 3004
Country 137494 0
Australia
Phone 137494 0
+61 438 009 787
Fax 137494 0
Email 137494 0
[email protected]
Contact person for public queries
Name 137495 0
Lewis Tan
Address 137495 0
Nucleus Network Pty Ltd, Level 3/549 St Kilda Rd Melbourne VIC 3004
Country 137495 0
Australia
Phone 137495 0
+61 3 8593 9801
Fax 137495 0
Email 137495 0
[email protected]
Contact person for scientific queries
Name 137496 0
Phillip Ryan
Address 137496 0
Nucleus Network Pty Ltd, 89 Commercial Road, Melbourne, VIC, 3004
Country 137496 0
Australia
Phone 137496 0
+61 438 009 787
Fax 137496 0
Email 137496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 18 months after last patient, last visit and EU and US approvals. No end date.
Available to whom?
Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose
Available for what types of analyses?
To achieve aims in the approved proposal
How or where can data be obtained?
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.


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.