A randomised, double-blind, placebo-controlled phase Ib trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ACD856 in healthy participants

2025-522287-32-00 Human pharmacology (Phase I) - Other Ended

Start 22 Oct 2025 · End 9 Apr 2026 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other
Status Ended
Participants planned 40
Countries 1
Sites 1

Depression

Key facts

Sponsor
AlzeCure Pharma AB
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03], Diseases [C] - Nervous System Diseases [C10]
Trial duration
22 Oct 2025 → 9 Apr 2026
Decision date (initial)
2025-09-10
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

Depression

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AlzeCure Pharma AB

Sponsor organisation
AlzeCure Pharma AB
Address
Halsovagen 7, Flemingsberg Flemingsberg
City
Huddinge
Postcode
141 57
Country
Sweden

Scientific contact point

Organisation
AlzeCure Pharma AB
Contact name
Märta Segerdahl

Public contact point

Organisation
AlzeCure Pharma AB
Contact name
Märta Segerdahl

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ended 40 1
Rest of world 0

Investigational sites

Sweden

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

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2025-10-22 2026-04-09 2025-10-22 2026-02-23

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-06-30 Sweden Acceptable
2025-09-08
2025-09-10