A Single Ascending Dose/Multiple Ascending Dose Study of JNJ-95597528 in Healthy Participants and a Proof of Mechanism Study in Participants with Mild to Moderate Asthma
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
Janssen Research & Development, LLC
76 participants
Dec 5, 2024
Interventional
Conditions
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.
Eligibility
Inclusion Criteria9
- For Healthy participants
- 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. Optional (Japanese cohort) : BMI between 17 and 32 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
- For Asthma Participants
- Otherwise healthy with no clinically significant abnormalities other than stable asthma with or without allergic rhinitis or mild atopic dermatitis as determined by medical history, physical examination, measurement of vital signs, and ECG
- Have been diagnosed by a physician with mild to moderate asthma for at least 6 months prior to screening
- Participant must have stable mild to moderate asthma that in the opinion of the investigator will not interfere with the assessment of safety of the study intervention
- Agree not to use prescription medications (with the exception of asthma medications) within 14 days prior to study intervention administration and through the duration of the study, unless approved by the investigator and sponsor medical monitor
Exclusion Criteria12
- For healthy participants
- 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
- For asthma participants
- Has a history of any other chronic respiratory condition including, but not limited to, chronic obstructive pulmonary disease (COPD), bronchiolitis, bronchiectasis, allergic bronchopulmonary aspergillosis (mycosis), occupational asthma, sleep apnea, pulmonary hypertension, or any other obstructive pulmonary disease
- Has elevated blood eosinophils for reasons other than asthma
- Has had a life-threatening asthma attack including respiratory arrest, intubation, or ICU admission due to asthma
- Have had an asthma exacerbation requiring augmentation of asthma therapy (increase in inhaled corticosteroids, addition of an additional asthma controller medication, antibiotics or systemic corticosteroids) within 6 months prior to screening or during the screening period
- Has received prescription medications other than protocol allowed asthma, allergic rhinitis, and atopic dermatitis medications within 2 weeks prior to first study intervention administration
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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. 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.
Locations(1)
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ACTRN12624001368527