ISRCTN ISRCTN15391202
DOI https://doi.org/10.1186/ISRCTN15391202
IRAS number 1007882
Secondary identifying numbers ETH47-101, IRAS 1007882
Submission date
04/12/2023
Registration date
04/12/2023
Last edited
04/12/2023
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

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

Mr Nigel Tomkinson
Scientific

Ethris GmbH
Semmelweisstrasse 3
Planegg
Munich
82152
Germany

Email info@ethris.com
Mr Nigel Tomkinson
Public

Ethris GmbH
Semmelweisstrasse 3
Planegg
Munich
82152
Germany

Email info@ethris.com
Dr Annelize Koch
Principal Investigator

Simbec-Orion Clinical Pharmacology
Merthyr Tydfil Industrial Park
Cardiff Road
Merthyr Tydfil
CF48 4DR
United Kingdom

Phone +44 (0)1443 694313
Email annelize.koch@simbecorion.com

Study information

Study designFirst-in-human trial in healthy participants
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Pharmaceutical testing facility
Study typeOther, Safety
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titlePhase 1 Trial: RD 799.35751 (ETH47-101)
Study hypothesisThe 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)

1. Approved 22/11/2023, Wales Research Ethics Committee 2 (Wales Research Ethics Committee 2, Health and Car Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2922 941119; Wales.REC2@wales.nhs.uk), ref: 23.WA.0186

2. Approved 22/11/2023, MHRA (MHRA, 10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 56586/0001/001-0001

ConditionHealthy volunteers
InterventionThe 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 typeDrug
Pharmaceutical study type(s)Pharmacokinetic, Pharmacodynamic
PhasePhase 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 measureThe 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.
Secondary outcome measuresThe 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.
Overall study start date23/02/2023
Overall study end date30/04/2024

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit55 Years
SexBoth
Target number of participants88
Participant inclusion criteriaThe 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.
Participant exclusion criteriaThe 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.
Recruitment start date29/11/2023
Recruitment end date09/04/2024

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Simbec Research Limited
Simbec House Merthyr Tydfil Industrial Park
Merthyr Tydfil Industrial Park
Pentrebach 
Merthyr Tydfil
Mid Glamorgan 
CF48 4DR
United Kingdom

Sponsor information

Ethris (Germany)
Industry

Semmelweisstrasse 3
Planegg
Munich
82152
Germany

Email info@ethris.com
Website https://www.ethris.com/
ROR logo "ROR" https://ror.org/05mz52w65

Funders

Funder type

Industry

Ethris GmbH

No information available

Results and Publications

Intention to publish date31/10/2026
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planFull 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 on or after the date of publication of full trial details.
IPD sharing planThe 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

04/12/2023: Study's existence confirmed by Wales Research Ethics Committee 2.