Clinical trial • Phase I | Phase III • Cardiology
Activin signaling inhibitor (specific active substance not stated) for Pulmonary arterial hypertension
Phase I | Phase III trial of Activin signaling inhibitor (specific active substance not stated) for Pulmonary arterial hypertension.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Pulmonary arterial hypertension
- Trial Stage
- Phase I | Phase III
Key dates
- Initial CTIS Submission Date
- 05-09-2025
- First CTIS Authorization Date
- 23-12-2025
Trial design
Placebo (added to background therapy); dose and schedule not specified.-controlled Phase I | Phase III trial in Hungary, Spain, Poland and others.
- Comparator
- Placebo (added to background therapy); dose and schedule not specified.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 17
Eligibility
Recruits 17 Vulnerable population selected; no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 17
- Recruitment Window Months
- 24
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 17
Hungary
- Earliest CTIS Part Ii Submission Date
- 03-12-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Semmelweis University
- Department Name
- Internal Medicine and Oncology
- Contact Person Name
- Istvan Takacs
- Contact Person Email
- takacs.istvan@semmelweis.hu
- Site Name
- University Of Szeged
- Department Name
- Clinical Pharmacology
- Contact Person Name
- Robert Takacs
- Contact Person Email
- takacs.robert@med.u-szeged.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 41
- Number Of Sites
- 9
- Number Of Participants
- 7
Sites
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Pulmonology
- Contact Person Name
- Sergio Cadenas Menendes
- Contact Person Email
- sercam.2007@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Cardiology
- Contact Person Name
- Pilar Escribano Subias
- Contact Person Email
- Pilar.escribano.subias@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pneumology
- Contact Person Name
- Manuel Lopez Meseguer
- Contact Person Email
- manuel.lopez@vallhebron.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Pulmonology
- Contact Person Name
- Sergio Alcolea Batres
- Contact Person Email
- alcobatres@yahoo.es
- Site Name
- Hospital Costa Del Sol
- Department Name
- Cardiology
- Contact Person Name
- Rafael Bravo Marques
- Contact Person Email
- rafabravomarques@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Pulmonology
- Contact Person Name
- Isabel Blanco
- Contact Person Email
- iblanco2@clinic.cat
- Site Name
- Hospital Universitario De Toledo
- Department Name
- Cardiology
- Contact Person Name
- Maria Lazaro
- Contact Person Email
- maria.lasal@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Pneumology
- Contact Person Name
- Jose Manuel Cifrian
- Contact Person Email
- josemanuel.cifrian@scsalud.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Cardiology
- Contact Person Name
- Alejandro Recio
- Contact Person Email
- JANDRORM@HOTMAIL.COM
Poland
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 87
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Department of Cardiac and Vascular Diseases
- Contact Person Name
- Grzegorz Kopeć
- Contact Person Email
- grzegorzkrakow1@gmail.com
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Kardiologii, Farmakologii Klinicznej i Chorób Wewnętrznych
- Contact Person Name
- Grzegorz Grześk
- Contact Person Email
- g.grzesk@cm.umk.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 02-03-2026
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Universitaetsmedizin Greifswald KöR
- Department Name
- Department of Internal Medicine, Respiratory Medicine and Infectious Diseases
- Contact Person Name
- Ralf Ewert
- Contact Person Email
- Ralf.Ewert@med.uni-greifswald.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- Centre for pulmonary hypertension
- Contact Person Name
- Ekkehard Grünig
- Contact Person Email
- ekkehard.gruenig@med.uni-heidelberg.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 10-03-2026
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Cardiology
- Contact Person Name
- Pavel Jansa
- Contact Person Email
- pavel.jansa@vfn.cz
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Cardiology
- Contact Person Name
- Hikmet Al-Hiki
- Contact Person Email
- hial@ikem.cz
Sponsor
Primary sponsor
- Full Name
- 35Pharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Canada
Investigational products
- Investigational Product Name
- HS235
- Active Substance
- Activin signaling inhibitor (specific active substance not stated)
- Combination Treatment
- Yes
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