Phase 1 trial HMR code: 23-011
| ISRCTN | ISRCTN17328380 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17328380 |
| IRAS number | 1009554 |
| Secondary identifying numbers | IRAS 1009554, HMR code: 23-011, Sponsor code: ASN51-105 |
- Submission date
- 26/03/2024
- Registration date
- 02/04/2024
- Last edited
- 29/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English Summary
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
Principal Investigator
Hammersmith Medicines Research Limited, Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Public, Scientific
Asceneuron S.A., EPFL Innovation Park, Bâtiment B
Lausanne
CH-1015
Switzerland
| Phone | + 41 21 353 8245 |
|---|---|
| asce-contact@asceneuron.com |
Study information
| Study design | Drug-drug interaction trial in up to 16 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Open-label |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| Scientific title | Phase 1 trial HMR code: 23-011 The full scientific title will be published within 30 months after the end of the trial |
| Study hypothesis | 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 04/04/2024, South Central – Oxford A Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 (0)207 104 8171; oxforda.rec@hra.nhs.uk), ref: 24/SC/0041 2. Approved 05/04/2024, Medicines and Healthcare products Regulatory Agency (MHRA) (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 50212/0004/001-0001 |
| Condition | Healthy volunteers |
| 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 | 16/02/2024 |
| Overall study end date | 22/09/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 16 |
| Participant inclusion criteria | Healthy human volunteer |
| Participant 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. |
| Recruitment start date | 23/04/2024 |
| Recruitment end date | 22/06/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW10 7EW
United Kingdom
Sponsor information
Industry
EPFL Innovation Park, Bâtiment B
Lausanne
CH-1015
Switzerland
| Phone | + 41 21 353 8245 |
|---|---|
| asce-contact@asceneuron.com | |
| Website | https://www.asceneuron.com/ |
"ROR" |
https://ror.org/02sbchm13 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 22/03/2027 |
|---|---|
| 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 1 study and the negligible benefit to the public of phase 1 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 29/04/2025 | No | No |
Additional files
Editorial Notes
29/04/2025: The basic results have been uploaded as an additional file.
15/05/2024: Dates of favourable opinion from the research ethics committee and MHRA notice of acceptance added.
02/04/2024: Study's existence confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA).
