Clinical trial • Phase I • Infectious Disease

plitidepsin for Viral diseases|Other specified diseases due to viruses

Phase I trial of plitidepsin for Viral diseases|Other specified diseases due to viruses. None/Not specified-controlled. 60 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Viral diseases|Other specified diseases due to viruses
Trial Stage
Phase I
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
22-11-2024
First CTIS Authorization Date
10-03-2025

Trial design

None/Not specified-controlled Phase I trial in Spain.

Comparator
None/Not specified
Target Sample Size
60

Recruitment

Planned Sample Size
60
Recruitment Window Months
17

Geography

Total Number Of Sites
1
Total Number Of Participants
60

Spain

Earliest CTIS Part Ii Submission Date
17-12-2024
Latest Decision Or Authorization Date
13-01-2026
Processing Time Days
392
Number Of Sites
1
Number Of Participants
60

Sites

Site Name
Hospital Universitario De La Princesa
Department Name
Clinical Pharmacology
Contact Person Name
Dolores Ochoa

Sponsor

Primary sponsor

Full Name
Pharma Mar S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Plitidepsin
Active Substance
plitidepsin
Modality
Peptide/protein/enzyme
Routes Of Administration
Intravenous
Route
Intravenous
Frequency
Single dose

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