Clinical trial • Phase I • Other
LB-0702
Phase I trial of LB-0702.
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, two treatment periods comparing: lb-0702 — single intravenous dose 1 µg/kg; nplate® — single intravenous dose 1 µg/kg.-controlled, crossover Phase I trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Two treatment periods comparing: LB-0702 — single intravenous dose 1 µg/kg; Nplate® — single intravenous dose 1 µg/kg.
- Crossover
- Yes
- Target Sample Size
- 34
Eligibility
Recruits 34 No vulnerable populations selected; trial population: healthy adult volunteers; no assent or special consent procedures specified in the record..
- Vulnerable Population
- No vulnerable populations selected; trial population: healthy adult volunteers; no assent or special consent procedures specified in the record.
Recruitment
- Planned Sample Size
- 34
- Recruitment Window Months
- 4
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 34
Spain
- Earliest CTIS Part Ii Submission Date
- 05-03-2025
- Latest Decision Or Authorization Date
- 06-08-2025
- Processing Time Days
- 154
- Number Of Sites
- 1
- Number Of Participants
- 34
Sites
- 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
- Routes Of Administration
- Intravenous
- Route
- IV
- Starting Dose
- 1 µg/kg
- Dose Levels
- 1 µg/kg (single dose)
- Frequency
- single dose
- Maximum Dose
- 1 µg/kg
- Investigational Product Name
- Nplate®
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intravenous
- Route
- IV
- Starting Dose
- 1 µg/kg
- Dose Levels
- 1 µg/kg (single dose)
- Frequency
- single dose
- Maximum Dose
- 1 µg/kg
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