Clinical trial • Phase I • Other
LB-0702
Phase I trial of LB-0702. Randomised, lb-0702 and nplate®; dose and schedule not specified-controlled. 106 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Stage
- Phase I
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 29-11-2024
- First CTIS Authorization Date
- 18-03-2025
Trial design
Randomised, lb-0702 and nplate®; dose and schedule not specified-controlled Phase I trial across 2 sites in Spain.
- Randomised
- Yes
- Comparator
- LB-0702 and Nplate®; dose and schedule not specified
- Target Sample Size
- 106
Recruitment
- Planned Sample Size
- 106
- Recruitment Window Months
- 7
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 106
Spain
- Earliest CTIS Part Ii Submission Date
- 05-03-2025
- Latest Decision Or Authorization Date
- 11-07-2025
- Processing Time Days
- 128
- Number Of Sites
- 2
- Number Of Participants
- 106
Sites
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Unidad de Ensayos Clínicos Fase I
- Contact Person Name
- Maria Dolores Ochoa
- Contact Person Email
- mdolores.ochoa@salud.madrid.org
- Site Name
- Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau
- Department Name
- Institut de Recerca - CIM-Sant Pau
- Contact Person Name
- Rosa Antonijoan
- Contact Person Email
- rantonijoana@santpau.cat
Sponsor
Primary sponsor
- Full Name
- Laboratorio Reig Jofre S.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- LB-0702
- Modality
- Peptide/protein/enzyme
- Investigational Product Name
- Nplate®
- Modality
- Peptide/protein/enzyme
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