Phase I trial, HMR code: 21-014
| ISRCTN | ISRCTN58651193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58651193 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2022-000511-31 |
| Integrated Research Application System (IRAS) | 1005035 |
| Protocol serial number | IRAS 1005035; HMR code: 21-014; Sponsor code: SLN501-001 |
| Sponsor | Silence Therapeutics (United Kingdom) |
| Funder | Silence Therapeutics |
- Submission date
- 18/05/2022
- Registration date
- 25/05/2022
- Last edited
- 27/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Scientific
HMR, Cumberland Avenue
London
NW10 7EW
United Kingdom
 ORCID ID |
0000-0001-8807-612X |
|---|---|
| Phone | +44 (0)20 8961 4130 |
| rec@hmrlondon.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | First-in-human safety, pharmacokinetics and pharmacodynamics trial in up to 32 healthy volunteers |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial, HMR code: 21-014 [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 19/05/2022, London–Brent (80 London Road, Skipton House, SE1 6LH, UK; +44 (0)20 7104 8128; brent.rec@hra.nhs.uk), ref: 22/LO/0242 2. Approved 23/05/2022, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, UK; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 49938/0005/001-0001 |
| 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 |
| 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(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. |
| Key secondary outcome measure(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. |
| Completion date | 14/10/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 32 |
| 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 | 30/05/2022 |
| Date of final enrolment | 14/10/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Park Royal
London
NW10 7EW
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
27/03/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 27/02/2023 to 14/10/2023.
2. The overall study end date was changed from 31/12/2023 to 14/10/2023.
08/08/2022: Ethics approval details added.
25/05/2022: Deferred status confirmed by the HRA.
25/05/2022: Trial's existence confirmed by the MHRA.
