Osprey
Research type
Research Study
Full 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.
IRAS ID
1011431
Contact name
Elena Bolanas
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2024-517644-62
Research summary
Background and study aim:
Asthma is a chronic (long-term) disease in which the bronchial airways in the lungs become narrowed and swollen, making it difficult to breathe. Atopic dermatitis (often occurring in patients with asthma) is an inflammatory condition which causes itchy, dry, red skin that occurs in people prone to allergies. Both these conditions may be treated by targeting interleukin-13 (IL-13)* & thymic stromal lymphopoietin (TSLP)*.
*IL-13 and TSLP are proteins that regulate immune responses.
JNJ-95597528 is a bispecific monoclonal antibody** that selectively blocks IL-13 & TSLP and relieves symptoms arising from inflammation mediated through IL-13 and TSLP.
** Type of protein that recognises & attaches to a specific target.
In this study, researchers want to learn how safe JNJ-95597528 is and how well it is being tolerated in asthma participants.Who can participate?
Participants aged 18 to 65 years with well-controlled mild to moderate asthma.What does the study involve?
Study will be conducted as follows:
1. Screening phase (28 days prior to first dose)
2. Treatment phase: Single dose of JNJ-95597528 or placebo given under the skin (subcutaneous) on Day 1.
3. Follow-up phase: up to approximately Week 65.
Safety assessments include monitoring of adverse events (AEs), clinical laboratory tests, physical examinations, vital signs and electrocardiogram (ECGs). All side effects will be recorded till the study ends or an AE has resolved.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
25/NW/0049
Date of REC Opinion
22 May 2025
REC opinion
Further Information Favourable Opinion