Clinical trial • Phase I • Dermatology
GTX-B001 for Cold-induced urticaria | Chronic inducible urticaria
Phase I trial of GTX-B001 for Cold-induced urticaria | Chronic inducible urticaria.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Cold-induced urticaria | Chronic inducible urticaria
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 06-06-2025
- First CTIS Authorization Date
- 27-08-2025
Trial design
Randomised, placebo (no dose or schedule specified)-controlled, adaptive Phase I trial across 2 sites in Germany.
- Randomised
- Yes
- Comparator
- Placebo (no dose or schedule specified)
- Adaptive
- True, Single Ascending Dose (dose-escalation) design; specific escalation rules, interim analyses or stopping rules not provided.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 56
Recruitment
- Planned Sample Size
- 56
- Recruitment Window Months
- 13
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 56
Germany
- Earliest CTIS Part Ii Submission Date
- 02-07-2025
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 258
- Number Of Sites
- 2
- Number Of Participants
- 56
Sites
- Site Name
- Fraunhofer Institute For Translational Medicine And Pharmacology ITMP
- Department Name
- Instituit für Translationale Medizin und Pharmakologie ITMP
- Contact Person Name
- Hanna Bonnekoh
- Contact Person Email
- study-coordination-berlin@itmp.fraunhofer.de
- Site Name
- Charite Research Organisation GmbH
- Department Name
- Charite Research Organisation
- Contact Person Name
- Martha Haidacher
- Contact Person Email
- info@charite-research.org
Sponsor
Primary sponsor
- Full Name
- Granular Therapeutics Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- GTX-B001
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