Phase I trial HMR code: 23-006

ISRCTN	ISRCTN23220202
DOI	https://doi.org/10.1186/ISRCTN23220202
IRAS number	1008812
Secondary identifying numbers	IRAS 1008812, HMR code: 23-006

Submission date: 26/01/2024
Registration date: 09/02/2024
Last edited: 09/02/2024

Recruitment status: 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 sponsor has confirmed that the trial meets the criteria for 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 Denisa Wilkes
Principal Investigator

HMR
Cumberland Avenue
London
NW10 7EW
United Kingdom

Phone	+44 (0)208 961 4130
Email	rec@hmrlondon.com

Dr Gedeon Richter Plc Medical Information Scientific Service -
Scientific

Gedeon Richter Plc
Gyömrői út 19-21
Budapest
H-1103
Hungary

Phone	+36 1 5057032
Email	medinfo@richter.hu

Dr Balázs Lázár
Public

Gedeon Richter Plc
Gyömrői út 19-21
Budapest
H-1103
Hungary

Phone	+36 204162804
Email	RA.ctaRichter@richter.hu

Study information

Study design	First-in-human safety, pharmacokinetics, and pharmacodynamics trial in up to 168 healthy volunteers
Primary study design	Interventional
Secondary study design	Randomized controlled trial; open-label cross-over trial
Study setting(s)	Other
Study type	Other
Participant information sheet	Not available in web format
Scientific title	Phase I trial HMR code: 23-006 [The full scientific title will be published within 30 months after the end of the trial]
Study objectives	The sponsor has confirmed that the trial meets the criteria for 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)	1. Approved 21/12/2023, Harrow Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 1048154; harrow.rec@hra.nhs.uk), ref: 23/LO/0809 2. Approved 04/01/2024, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 04854/0225/001-0001
Health condition(s) or problem(s) studied	The sponsor has confirmed that the trial meets the criteria for 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 sponsor has confirmed that the trial meets the criteria for 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
Pharmaceutical study type(s)	The sponsor has confirmed that the trial meets the criteria for 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.
Phase	Phase I
Drug / device / biological / vaccine name(s)	The sponsor has confirmed that the trial meets the criteria for 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	The sponsor has confirmed that the trial meets the criteria for 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.
Secondary outcome measures	The sponsor has confirmed that the trial meets the criteria for 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.
Overall study start date	06/11/2023
Completion date	08/11/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Both
Target number of participants	Up to 168
Key inclusion criteria	Healthy human volunteer
Key exclusion criteria	The sponsor has confirmed that the trial meets the criteria for 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	13/02/2024
Date of final enrolment	08/08/2025

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

HMR

Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom

Sponsor information

Gedeon Richter (Hungary)
Industry

Gedeon Richter Plc
Gyömrői út 19-21
Budapest
H-1103
Hungary

Email	RA.ctaRichter@richter.hu
"ROR"	https://ror.org/0033rtn64

Funders

Funder type

Industry

Gedeon Richter
Private sector organisation / For-profit companies (industry)

Location: Hungary

Results and Publications

Intention to publish date	08/05/2028
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Full trial details will be published up to 30 months after the end of the trial. Publication of some trial details is deferred because of the high commercial sensitivity of this Phase I study and the negligible benefit to the public of Phase I information. Results will be posted after the end of the Phase II trial.
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.

Editorial Notes

07/02/2024: Study's existence confirmed by the MHRA.