Clinical trial • Phase I • Infectious Disease

Isoniazid for Tuberculosis

Phase I trial of Isoniazid for Tuberculosis. 8 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Tuberculosis
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-10-2024
First CTIS Authorization Date
29-11-2024

Trial design

Phase I trial across 1 site in Netherlands.

Target Sample Size
8

Recruitment

Planned Sample Size
8
Recruitment Window Months
24

Geography

Total Number Of Sites
1
Total Number Of Participants
8

Netherlands

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
29-11-2024
Processing Time Days
18
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
UMCG
Department Name
Pulmonary Diseases & Tuberculosis
Contact Person Name
Onno Akkerman
Contact Person Email
o.w.akkerman@umcg.nl

Sponsor

Primary sponsor

Full Name
Universitair Medisch Centrum Groningen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Isoniazid (INH) inhalation
Active Substance
Isoniazid
Modality
Small molecule
Routes Of Administration
Inhalation (nebulization)
Route
Inhalation (nebulization)

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