A Phase 1, open label, randomised, 2-period, 2 sequence, 7-days repeat-dosing, crossover oral pharmacokinetic trial comparing multiple dosing of CS014 to valproic acid in healthy adults.

2025-524883-39-00 Protocol CS014-002 Human pharmacology (Phase I) - Other Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol CS014-002

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Authorised, recruitment pending
Participants planned 14
Countries 1
Sites 1

Cardiopulmonary diseases with contributions of thrombosis, remodelling of pulmonary vessels and fibrosis.

Key facts

Sponsor
Cereno Scientific AB
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2026-03-17
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Cardiopulmonary diseases with contributions of thrombosis, remodelling of pulmonary vessels and fibrosis.

VersionLevelCodeTermSystem organ class
20.0 LLT 10020787 Hypertension pulmonary 10038738
21.1 PT 10021240 Idiopathic pulmonary fibrosis 100000004855

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cereno Scientific AB

2 Total trials 1 Ended
Commercial
Sponsor organisation
Cereno Scientific AB
Address
Forandringens Gata 10, Fassberg Fassberg
City
Molndal
Postcode
431 53
Country
Sweden

Scientific contact point

Organisation
Cereno Scientific AB
Contact name
Björn Dahlöf, Chief Scientific Officer

Public contact point

Organisation
Cereno Scientific AB
Contact name
Tove Bergenholt, Head of IR & Communications

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Authorised, recruitment pending 14 1
Rest of world — 0 —

Investigational sites

Sweden

1 site · Authorised, recruitment pending
CTC Clinical Trial Consultants AB
CTC, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-01-29 Sweden Acceptable
2026-03-17
 2026-03-17