Phase Ib Trial: 273391
| ISRCTN | ISRCTN93130126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93130126 |
| EudraCT/CTIS number | 2023-507340-36-00 |
| IRAS number | 1009618 |
| Secondary identifying numbers | IRAS 1009618 |
- Submission date
- 12/04/2024
- Registration date
- 12/04/2024
- Last edited
- 30/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Principal Investigator
Parexel Early Phase Clinical Unit - Northwick Park Hospital
Level 7 Watford Road
Harrow
London
HA1 £UJ
United Kingdom
| Phone | +44 (0)1895614973 |
|---|---|
| david.steel@parexel.com |
Scientific
Via Visconti di Modrone Uberto 18
Milan
20122
Italy
| Phone | +39 (0)3456306238 |
|---|---|
| filippo.canducci@entherapharmaceuticals.com |
Public
Via Visconti di Modrone Uberto 18
milan
20122
Italy
| Phone | +39 (0)249533580 |
|---|---|
| raffaella.maucci@entherapharmaceuticals.com |
Study information
| Study design | Safety, tolerability, and pharmacokinetics study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Safety |
| Participant information sheet | Not available in web format |
| Scientific title | Phase Ib Trial: 273391 |
| 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 02/04/2024, London - Riverside REC (2 Redman Place, London, E20 1JQ, United Kingdom; +44 (0)2071048150; riverside.rec@hra.nhs.uk), ref: 24/LO/0180 |
| 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 |
| Pharmaceutical study type(s) | Pharmacokinetic, Tolerability, immunogenicity |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 03/04/2024 |
| Completion date | 10/02/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 55 |
| 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 | 03/04/2024 |
| Date of final enrolment | 03/06/2024 |
Locations
Countries of recruitment
- Bulgaria
- England
- Georgia
- Hungary
- Moldova
- Netherlands
- Romania
- United Kingdom
Study participating centre
Level 7, Watford Road
Harrow
HA1 3UJ
United Kingdom
Sponsor information
Industry
Via Visconti di Modrone Uberto 18
Milan
20122
Italy
| Phone | +39 (0)2 49533580 |
|---|---|
| info@entherapharmaceuticals.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 10/08/2027 |
|---|---|
| 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 on or after the date of publication of full trial details. |
| 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
30/10/2024: Contact and sponsor details updated.
09/05/2024: Contact details updated.
13/02/2024: Study's existence confirmed by Health Research Authority (HRA) (UK).
