First-in-human (FIH), microdosing, non-randomized, clinical trial to investigate binding of positron emission tomography tracer [68Ga]Ga-DOTA-Cys-ATH001 targeting platelet derived growth factor receptor β in healthy subjects as compared to patients with metabolic dysfunction-associated steatohepatitis (MASH) and Primary Sclerosing Cholangitis binding (PSC, liver) and patients with fibrostenotic Crohn’s disease (CD, gastrointestinal tract [GI])

2023-506555-15-00 Protocol INT008 Human pharmacology (Phase I) - First administration to humans Ongoing, recruiting

Start 19 Aug 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 3 sites · Protocol INT008

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans
Status Ongoing, recruiting
Participants planned 30
Countries 1
Sites 3

Metabolic dysfunction-associated steatotic liver disease

Key facts

Sponsor
Antaros Medical AB
Participant type
Healthy volunteers, Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trial duration
19 Aug 2024 → ongoing
Decision date (initial)
2024-05-07
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

Metabolic dysfunction-associated steatotic liver disease

VersionLevelCodeTermSystem organ class
24.1 LLT 10086076 Fibrostenotic Crohn´s disease 100000004848
20.0 PT 10076331 Steatohepatitis 100000004871
20.1 LLT 10036732 Primary sclerosing cholangitis 10019805

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Antaros Medical AB

2 Total trials 1 Recruiting
Commercial
Sponsor organisation
Antaros Medical AB
Address
Pepparedsleden 1, Fassberg Fassberg
City
Molndal
Postcode
431 53
Country
Sweden

Scientific contact point

Organisation
Antaros Medical AB
Contact name
Lars Johansson

Public contact point

Organisation
Antaros Medical AB
Contact name
Lars Johansson

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ongoing, recruiting 30 3
Rest of world — 0 —

Investigational sites

Sweden

3 sites · Ongoing, recruiting
Uppsala University Hospital
Section of Gastroenterology/Hepatology, Akademiska Sjukhuset, 751 85, Uppsala
CTC Clinical Trial Consultants AB
CTC, Dag Hammarskjolds Vag 10b, Uppsala Domkyrkofors., Uppsala
CTC Clinical Trial Consultants AB
CTC, Karolinska Vagen 22, 171 64, Solna

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 2024-08-19 2024-08-19

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-02-15 Sweden Acceptable
2024-04-30
 2024-05-07
2 SUBSTANTIAL MODIFICATION SM-1 2025-02-11 Sweden Acceptable
2025-04-09
 2025-04-14
3 SUBSTANTIAL MODIFICATION SM-2 2025-09-02 Sweden Acceptable
2025-10-09
 2025-10-14
4 SUBSTANTIAL MODIFICATION SM-4 2025-11-28 Sweden Acceptable
2026-01-22
 2026-01-23

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