Clinical trial • Phase I • Respiratory
JNJ-95597528 for Asthma (mild to moderate)
Phase I trial of JNJ-95597528 for Asthma (mild to moderate). Randomised, placebo (placebo control), adaptive. 66 participants.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Asthma (mild to moderate)
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 06-02-2025
- First CTIS Authorization Date
- 03-06-2025
Trial design
Randomised, placebo (placebo control), adaptive Phase I trial across 3 sites in Germany, Belgium.
- Randomised
- Yes
- Comparator
- Placebo (placebo control)
- Adaptive
- True - single ascending dose escalation; dose escalation rules not specified in the record.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 66
Eligibility
Recruits 66 No vulnerable populations selected; no specific consent or assent handling described in the record..
- Vulnerable Population
- No vulnerable populations selected; no specific consent or assent handling described in the record.
Recruitment
- Planned Sample Size
- 66
- Recruitment Window Months
- 21
- Consent Approach
- Informed consent approach not described; no details on assent, age-specific documents, or languages.
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 46
Germany
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 231
- Number Of Sites
- 2
- Number Of Participants
- 26
Sites
- Site Name
- Charite Research Organisation GmbH
- Department Name
- Medical Operations
- Contact Person Name
- Stanislav Ignatenko
- Contact Person Email
- stanislav.ignatenko@charite-research.org
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- lnstitut fuer klinische Forschung Pneumologie
- Contact Person Name
- Oliver Kornmann
- Contact Person Email
- kornmann@ikf-pneumologie.de
Belgium
- Earliest CTIS Part Ii Submission Date
- 18-04-2025
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 223
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- SGS Belgium
- Department Name
- SGS NV - Clinical Pharmacology Unit
- Contact Person Name
- Thomas De Ridder
- Contact Person Email
- thomas.deridder@sgs.com
Sponsor
Primary sponsor
- Full Name
- Janssen Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-95597528
- First In Human
- Yes
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