Clinical trial • Phase I • Gastroenterology
GRT-001 for Ulcerative colitis
Phase I trial of GRT-001 for Ulcerative colitis. Randomised, placebo (placebo-controlled; dose and schedule not specified), adaptive. 112 participants.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Ulcerative colitis
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 12-10-2023
- First CTIS Authorization Date
- 11-01-2024
Trial design
Randomised, placebo (placebo-controlled; dose and schedule not specified), adaptive Phase I trial across 1 site in Germany.
- Randomised
- Yes
- Comparator
- Placebo (placebo-controlled; dose and schedule not specified)
- Adaptive
- True - single and multiple-dose-escalation design mentioned; specific escalation rules/interim analyses not provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 112
Recruitment
- Planned Sample Size
- 112
- Recruitment Window Months
- 36
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 112
Germany
- Earliest CTIS Part Ii Submission Date
- 24-11-2023
- Latest Decision Or Authorization Date
- 13-03-2026
- Processing Time Days
- 840
- Number Of Sites
- 1
- Number Of Participants
- 112
Sites
- Site Name
- Charite Research Organisation GmbH
- Contact Person Name
- Stanislav Ignatenko
- Contact Person Email
- Stanislav.Ignatenko@charite-research.org
Sponsor
Primary sponsor
- Full Name
- Granite Bio AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- GRT-001
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