Phase 1 Trial: EMP-012-1
| ISRCTN | ISRCTN55493273 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55493273 |
| IRAS number | 1011107 |
| Secondary identifying numbers | 1011107/EMP-012-1 |
- Submission date
- 24/02/2025
- Registration date
- 26/02/2025
- Last edited
- 26/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Deferred
- Condition category
- Other
Plain English summary of protocol
The Health Research Authority (HRA) has approved 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
Medicines Evaluation Unit
The Langley Building, Southmoor Road
Manchester
M23 9Qz
United Kingdom
| Phone | +44 0161 946 4073 |
|---|---|
| dsingh@meu.org.uk |
Public, Scientific
4660 La Jolla Village Drive
Suite 100
San Diego
92122
United States of America
| Phone | +1 949 403 0828 |
|---|---|
| michael.molyneaux@empiricotx.com |
Study information
| Study design | First-in-man safety pharmacokinetic and pharmacodynamics trial in 80 subjects including healthy volunteers and patients |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Phase 1 Trial: EMP-012-1 |
| Study objectives | The Health Research Authority (HRA) has approved 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 13/02/2025, North East-York Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8079; York.rec@hra.nhs.uk), ref: 25/NE/0004 |
| Health condition(s) or problem(s) studied | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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) | Pharmacokinetic, Pharmacodynamic |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | The Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 Health Research Authority (HRA) has approved 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 | 18/12/2024 |
| Completion date | 18/12/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key inclusion criteria | The Health Research Authority (HRA) has approved 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 exclusion criteria | The Health Research Authority (HRA) has approved 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 | 24/02/2025 |
| Date of final enrolment | 20/05/2026 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
Study participating centre
Southmoor Road
Wythenshawe
Manchester
M23 9QZ
United Kingdom
Sponsor information
Industry
4660 La Jolla Village Drive
Suite 100
San Diego
92122
United States of America
| Phone | +1 949 403 0828 |
|---|---|
| Michael.Molyneaux@empiricotx.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 18/06/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The Health Research Authority (HRA) has approved 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. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
25/02/2025: Study's existence confirmed by Health Research Authority (HRA) (UK)
