Phase I trial; HMR code: 24-003
| ISRCTN | ISRCTN16055614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16055614 |
| IRAS number | 1010220 |
| Secondary identifying numbers | IRAS 1010220; HMR code: 24-003; Sponsor code: SLG-TED-101 |
- Submission date
- 05/08/2024
- Registration date
- 12/08/2024
- Last edited
- 06/01/2025
- Recruitment status
- 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
Park Royal
London
NW10 7EW
United Kingdom
| Phone | +44 20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Public, Scientific
455 E. Eisenhower Parkway
Suite 300 PMB 1048
Ann Arbor
MI 48108
United States of America
| Phone | +1 734 887 9192 |
|---|---|
| info@slingtx.com |
Study information
| Study design | Pharmacokinetic and bioavailability study in up to 20 healthy volunteers |
|---|---|
| Primary study design | Interventional |
| Secondary study design | |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format |
| Scientific title | Phase I trial; HMR code: 24-003 [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) |
Approved 30/07/2024, London – Surrey Borders Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 207 104 8057; surreyborders.rec@hra.nhs.uk), ref: 24/LO/0492 |
| 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 | 05/06/2024 |
| Overall study end date | 08/08/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 20 |
| Participant inclusion criteria | Healthy 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 | 14/08/2024 |
| Recruitment end date | 08/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW10 7EW
United Kingdom
Sponsor information
Industry
455 E. Eisenhower Parkway
Suite 300 PMB 1048
Ann Arbor
MI 48108
United States of America
| Phone | +1 734 887 9192 |
|---|---|
| info@slingtx.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 08/02/2028 |
|---|---|
| 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 may 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
06/01/2025: The following changes were made to the study record:
1. The recruitment end date was changed from 24/10/2024 to 08/05/2025.
2. The overall study end date was changed from 24/01/2025 to 08/08/2025.
3. The intention to publish date was changed from 24/07/2027 to 08/02/2028.
12/08/2024: Study's existence confirmed by the MHRA.
