Clinical trial • Phase I • Infectious Disease|Neurology

IM-250 for Herpes simplex virus encephalitis | Herpes simplex encephalitis

Phase I trial of IM-250 for Herpes simplex virus encephalitis | Herpes simplex encephalitis. adaptive. 30 participants.

Overview

Trial Therapeutic Area
Infectious Disease|Neurology
Trial Disease
Herpes simplex virus encephalitis | Herpes simplex encephalitis
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
05-08-2025
First CTIS Authorization Date
18-11-2025

Trial design

adaptive Phase I trial across 1 site in Bulgaria.

Adaptive
Yes
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
30

Recruitment

Planned Sample Size
30
Recruitment Window Months
12

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Bulgaria

Earliest CTIS Part Ii Submission Date
12-08-2025
Latest Decision Or Authorization Date
18-11-2025
Processing Time Days
98
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Diagnostics And Consultation Center Convex Ltd.
Department Name
Clinical Pharmacology
Contact Person Name
Andrey Petrov
Contact Person Email
andrewpbg@yahoo.com
Number Of Participants
30

Sponsor

Primary sponsor

Full Name
Fuics Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
Cyprus

Investigational products

Investigational Product Name
IM-250
Routes Of Administration
Intravenous
Route
Intravenous
Frequency
Single ascending doses

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