Clinical trial • Phase I • Cardiology|Respiratory

Valproic acid for Pulmonary hypertension | Idiopathic pulmonary fibrosis | Cardiopulmonary disease

Phase I trial of Valproic acid for Pulmonary hypertension | Idiopathic pulmonary fibrosis | Cardiopulmonary disease.

Overview

Trial Therapeutic Area
Cardiology|Respiratory
Trial Disease
Pulmonary hypertension | Idiopathic pulmonary fibrosis | Cardiopulmonary disease
Trial Stage
Phase I
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-01-2026
First CTIS Authorization Date
17-03-2026

Trial design

Randomised, open-label, valproic acid (comparator) - dose and schedule not specified; cs014 (investigational) - dose and schedule not specified.-controlled, crossover Phase I trial across 1 site in Sweden.

Randomised
Yes
Open Label
Yes
Comparator
Valproic acid (comparator) - dose and schedule not specified; CS014 (investigational) - dose and schedule not specified.
Crossover
Yes
Target Sample Size
14

Recruitment

Planned Sample Size
14
Recruitment Window Months
1

Geography

Total Number Of Sites
1
Total Number Of Participants
14

Sweden

Earliest CTIS Part Ii Submission Date
06-03-2026
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
11
Number Of Sites
1
Number Of Participants
14

Sites

Site Name
CTC Clinical Trial Consultants AB
Department Name
CTC
Contact Person Name
Johan Nilsson
Contact Person Email
johan.nilsson@ctc-ab.se

Sponsor

Primary sponsor

Full Name
Cereno Scientific AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
CS014
Modality
Small molecule
Routes Of Administration
oral
Route
oral
Investigational Product Name
Valproic acid
Active Substance
Valproic acid
Modality
Small molecule
Routes Of Administration
oral
Route
oral

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