Phase I trial, HMR code: 21-014
| ISRCTN | ISRCTN58651193 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58651193 |
| EudraCT/CTIS number | 2022-000511-31 |
| IRAS number | 1005035 |
| Secondary identifying numbers | IRAS 1005035; HMR code: 21-014; Sponsor code: SLN501-001 |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Malcolm Boyce
Scientific
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
| Study design | First-in-human safety, pharmacokinetics and pharmacodynamics trial in up to 32 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| 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 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 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 |
| Condition | 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) | |
| 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 | 21/03/2022 |
| Overall study end date | 14/10/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 32 |
| 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 | 30/05/2022 |
| Recruitment end date | 14/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
HMR
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom
Park Royal
London
NW10 7EW
United Kingdom
Sponsor information
Silence Therapeutics (United Kingdom)
Industry
Industry
72 Hammersmith Road
London
W14 8TH
England
United Kingdom
| Phone | +44 (0)20 3457 6900 |
|---|---|
| LEGAL@silence-therapeutics.com | |
| Website | https://www.silence-therapeutics.com/ |
"ROR" |
https://ror.org/03p3e4237 |
Funders
Funder type
Industry
Silence Therapeutics
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Silence Therapeutics plc
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Trial information and summary results 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 I information. |
| 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
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.
