A research study to evaluate the effects of single doses of NNC0614-0001 in healthy adult volunteers, and participants with hereditary haemochromatosis type 1.

Start 6 Sep 2024 · End 13 May 2026 · Status Ended · 1 EU/EEA countries · 1 sites · Protocol NN7614-7656

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - Other

Status Ended

Participants planned 66

Countries 1

Sites 1

Hereditary haemochromatosis (HH) type 1

Sponsor: Novo Nordisk A/S
Participant type: Healthy volunteers, Patients
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16], Diseases [C] - Hemic and Lymphatic Diseases [C15]
Trial duration: 6 Sep 2024 → 13 May 2026
Decision date (initial): 2024-07-29
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

CTIS Part I — objectives, methods, condition coding

Hereditary haemochromatosis (HH) type 1

Sponsor organisations, regulatory contacts, third parties

1 EU/EEA country · 1 investigational sites

Country	MS status	Planned subjects	Sites
Austria	Ended	66	1
Rest of world	—	0	—

1 site · Ended

Medical University Of Graz

Department of Internal Medicine, Neue Stiftingtalstrasse 6, 8010, Graz

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Austria	2024-09-06		2024-09-18	2025-11-18

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-04-05	Austria	Acceptable 2024-07-22	2024-07-29
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-07-30	Austria	Acceptable 2024-07-22	2025-07-30
3	SUBSTANTIAL MODIFICATION	SM-1	2025-11-04	Austria	Acceptable 2025-12-22	2025-12-29