Comparison of Zinc Acetate Dose Regimens (Galzin vs. ET-700) for the Treatment of Wilson Disease: a Pharmacodynamic 64CUCL2 Pet/Ct Study in Healthy Participants

2025-523372-24-00 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 10 Mar 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 36
Countries 1
Sites 1

Wilson's Disease

The aim of the study is to investigate the effect of Galzin 50 mg three times daily, ET-700 75 mg twice daily, and placebo on intestinal copper absorption in healthy volunteers. Using 64Cu PET/CT scans, we can assess intestinal copper absorption by measuring the amount of 64Cu in the liver.

Key facts

Sponsor
Region Midtjylland
Participant type
Healthy volunteers
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
10 Mar 2026 → ongoing
Decision date (initial)
2026-03-02
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
No
Funding sources
Eton Pharmaceuticals

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacodynamic, Therapy, Safety

The aim of the study is to investigate the effect of Galzin 50 mg three times daily, ET-700 75 mg twice daily, and placebo on intestinal copper absorption in healthy volunteers. Using 64Cu PET/CT scans, we can assess intestinal copper absorption by measuring the amount of 64Cu in the liver.

Conditions and MedDRA coding

Wilson's Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Age above 18 years.
  2. BMI below 30.
  3. Women of child-bearing potential (WOCBP) must agree to use reliable contraception from the inclusion; intrauterine device (IUD) or hormonal contraception (oral contraceptives, implant, transdermal patch, vaginal ring, or depot injection) until 14 days after the last scan unless they for religious or personal reasons are sexually abstinent.
  4. On the day of the tracer intake, fertile women must have a negative urine pregnancy test.
  5. Signed informed consent must be obtained before any trial-related examinations are performed.
  6. Ability to read and understand Danish sufficiently to comply with study procedures and provide informed consent.

Exclusion criteria 6

  1. Exposure to X-ray examinations during the last 12 months.
  2. Known hypersensitivity to copper, 64CuCl2 (the tracer), or to any components of the Galzin® or ET-700 formulations.
  3. Deemed unsuitable by a physician based on abnormal inclusion blood tests.
  4. Known contraindications to Galzin treatment (please refer to the IMPD in Part I).
  5. Claustrophobia.
  6. Pregnancy, breastfeeding, or planning to become pregnant before the study is completed.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is the change in mean hepatic 64Cu standard uptake value (SUV) from pre- to post-intervention between the three groups.

Secondary endpoints 4

  1. Change in plasma zinc, total copper, exchangeable copper, and ceruloplasmin levels from pre- to post-intervention between the groups.
  2. Change in metallothionein (a protein related to homeostasis of e.g. zinc and copper) induction in peripheral blood mononuclear cells from pre- to post-intervention between the groups.
  3. Change in urinary zinc and copper levels from pre- to post-intervention between the groups.
  4. Number of AEs in the three groups.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

ET-700 75 mg

PRD12952607 · Product

Active substance
Zinc
Pharmaceutical form
CAPSULES
Route of administration
ORAL
Max daily dose
0.15 g gram(s)
Max total dose
4.2 g gram(s)
Max treatment duration
4 Week(s)
Authorisation status
Not Authorised
MA holder
REGION MIDTJYLLAND
Paediatric formulation
No
Orphan designation
No

Comparator 1

Galzin 50mg

PRD12952606 · Product

Active substance
Zinc
Pharmaceutical form
CAPSULES
Route of administration
ORAL
Max daily dose
0.15 g gram(s)
Max total dose
4.2 g gram(s)
Max treatment duration
4 Week(s)
Authorisation status
Not Authorised
MA holder
REGION MIDTJYLLAND
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
ODD-1999-0502

Placebo 1

Placebo

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 1

Copper (64CU) Chloride

SUB77003 · Substance

Active substance
Copper (64CU) Chloride
Pharmaceutical form
RADIOPHARMACEUTICAL PRECURSOR, SOLUTION
Route of administration
ORAL
Max daily dose
30 MBq megabecquerel(s)
Max total dose
30 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

59 Total trials 36 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Midtjylland
Address
Palle Juul-Jensens Boulevard 99
City
Aarhus N
Postcode
8200
Country
Denmark

Scientific contact point

Organisation
Region Midtjylland
Contact name
Afdeling for Lever-, Mave- og Tarmsygdomme

Public contact point

Organisation
Region Midtjylland
Contact name
Afdeling for Lever-, Mave- og Tarmsygdomme

Third parties 1

OrganisationCity, countryDuties
Aarhus Universitet
ORG-100028380
 Aarhus N, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 36 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Region Midtjylland
Hepatology & Gastroenterology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2026-03-10 2026-03-17

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_ Protocol 2025-523372-24-00 3
Protocol (for publication) D4_ Patient facing documents IMP Log Book 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements 2
Recruitment arrangements (for publication) K2_ Recruitment material Aarhus Onsdag 2
Recruitment arrangements (for publication) K2_ Recruitment material Facebook 2
Recruitment arrangements (for publication) K2_ Recruitment material Forsgspersoner 2
Recruitment arrangements (for publication) K2_ Recruitment material Poster 2
Subject information and informed consent form (for publication) L1_ ICF Addition 1
Subject information and informed consent form (for publication) L1_ ICF Participation 1
Subject information and informed consent form (for publication) L1_ SIS 2
Subject information and informed consent form (for publication) L2_ Other subject information material Medical Research Ethics Committee 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Galzin 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-10-30 Denmark Acceptable
2026-02-05
 2026-03-02

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