Clinical trial • Phase I • Haematology
QL0911 for Immune thrombocytopenia | Hematopoietic syndrome of acute radiation syndrome
Phase I trial of QL0911 for Immune thrombocytopenia | Hematopoietic syndrome of acute radiation syndrome. Randomised, crossover. 76 participants.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Immune thrombocytopenia | Hematopoietic syndrome of acute radiation syndrome
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 30-09-2025
- First CTIS Authorization Date
- 26-01-2026
Trial design
Randomised, crossover Phase I trial across 1 site in Poland.
- Randomised
- Yes
- Crossover
- Yes
- Target Sample Size
- 76
Eligibility
Recruits 76 Vulnerable population not selected; population: Healthy volunteers; both male and female subjects. No consent/assent details provided..
- Vulnerable Population
- Vulnerable population not selected; population: Healthy volunteers; both male and female subjects. No consent/assent details provided.
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 11
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 76
Poland
- Earliest CTIS Part Ii Submission Date
- 14-12-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 43
- Number Of Sites
- 1
- Number Of Participants
- 76
Sites
- Site Name
- Mtz Clinical Research Powered By Pratia
- Department Name
- Clinical Unit
- Contact Person Name
- Anna Dryja
- Contact Person Email
- anna.dryja@pratia.com
- Number Of Participants
- 76
Sponsor
Primary sponsor
- Full Name
- Qilu Pharmaceutical Co. Ltd.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- China
Investigational products
- Investigational Product Name
- QL0911
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