Phase I trial; HMR code: 24-003
| ISRCTN | ISRCTN16055614 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16055614 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1010220 |
| Protocol serial number | IRAS 1010220; HMR code: 24-003; Sponsor code: SLG-TED-101 |
| Sponsor | Sling Therapeutics, Inc. |
| Funder | Sling Therapeutics, Inc. |
- Submission date
- 05/08/2024
- Registration date
- 12/08/2024
- Last edited
- 06/01/2025
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Pharmacokinetic and bioavailability study in up to 20 healthy volunteers |
| Secondary study design | |
| Study type | Participant information sheet |
| 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 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) |
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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 | 08/08/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | Healthy 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 | 14/08/2024 |
| Date of final enrolment | 08/05/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
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
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.
