None listed
Conditions
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. For Optional Asthma Cohort: The purpose of this part is to evaluate the safety and tolerability of JNJ-95597528 in participants with mild to moderate asthma.
Interventions
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 th
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.
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. One of the optional SAD5 through SAD7 cohorts may be used to enroll a Japanese specific healthy participant cohort.
Arm 2 - Optional Asthma Cohort; Typ
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. One of the optional SAD5 through SAD7 cohorts may be used to enroll a Japanese specific healthy participant cohort. Arm 2 - Optional Asthma Cohort; Type: Experimental; Description: Participants in Part 2 with well-controlled mild to moderate stable asthma will receive a single dose of JNJ-95597528 or placebo through SC administration on Day 1. Arm 3: 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 Type: Drug Intervention name: JNJ-95597528 Associated arms: Single Ascending Dose (SAD) and Optional Multiple Ascending Dose (MAD) Cohort Intervention Description: 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 Type: Drug Intervention name: JNJ-95597528 Associated arms: Optional Asthma Cohort Intervention description: JNJ-95597528 will be administered at a dose decided by DRC. It will be administered by medical professionals including registered nurses through subcutaneous injection. No monitoring adherence will be performed.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
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
Outcome results
None listed