Phase I trial: Fortrea Phase I unit Leeds

ISRCTN	ISRCTN22812347
DOI	https://doi.org/10.1186/ISRCTN22812347
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	2024-000381-25
Integrated Research Application System (IRAS)	1009954
Protocol serial number	IRAS 1009954 Fortrea Phase I unit Leeds
Sponsor	Pharmacosmos (Denmark)
Funder	Pharmacosmos

Submission date: 09/01/2025
Registration date: 10/01/2025
Last edited: 10/01/2025

Recruitment status: No longer recruiting
Overall study status: Deferred
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.

Contact information

Dr Jim Bush
Principal investigator

Fortrea Clinical Research Unit Ltd
Drapers Yard
Marshall St
Holbeck
Leeds
LS11 9EH
United Kingdom

Phone	+44 (0)1133013590
Email	ukirelandregethics@fortrea.com

Mr Clinical Scientist
Scientific

Roervangsvej, 30
Holbaek
4300
Denmark

Phone	+45 (0)59 48 59 59
Email	info@pharmacosmos.com

Mr Head Of Clinical Development
Public

Roervangsvej 30
Holbaek
4300
Denmark

Phone	+45 (0)59 48 59 59
Email	info@pharmacosmos.com

Study information

Primary study design	Interventional
Study design	Human AME trial in 6 healthy volunteers and 6 iron-overloaded patients
Secondary study design
Study type	Participant information sheet
Scientific title	Phase I trial: Fortrea Phase I unit Leeds [The full scientific title will be published within 30 months after the end of the trial]
Study objectives	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Ethics approval(s)	Approved 12/11/2024, North East-York (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; york.rec@hra.nhs.uk), ref: 24/NE/0138
Health condition(s) or problem(s) studied	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Intervention type	Drug
Phase	Phase I
Drug / device / biological / vaccine name(s)	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Primary outcome measure(s)	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Key secondary outcome measure(s)	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Completion date	27/02/2025

Eligibility

Participant type(s)	Healthy volunteer, Patient
Age group	Adult
Sex	All
Target sample size at registration	12
Key inclusion criteria	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Key exclusion criteria	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial. The full details will be added to the study record within 30 months after the trial has ended.
Date of first enrolment	28/11/2024
Date of final enrolment	12/02/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Fortrea Phase I unit

Drapers Yard
Marshall Street
Leeds
LS 11 9EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated and/or analysed during the current study are not expected to be made available because of their high commercial sensitivity and the negligible benefit to the public of publication of results of non-therapeutic clinical trials.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/01/2025: Study's existence confirmed by the HRA.