Phase I trial HMR code: 23-503
| ISRCTN | ISRCTN70080074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70080074 |
| IRAS number | 1008987 |
| Secondary identifying numbers | IRAS 1008987, HMR code: 23-503 |
- Submission date
- 31/01/2024
- Registration date
- 15/02/2024
- Last edited
- 02/05/2024
- Recruitment status
- 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
HMR, Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Public
Nxera Pharma UK Ltd
Steinmetz Building
Granta Park
Great Abington
Cambridge
CB21 6DG
United Kingdom
| Phone | +44 (0)1223 949 100 |
|---|---|
| reception@nxera.life |
Scientific
HMR, Cumberland Avenue
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Study information
| Study design | First-in-human safety, pharmacokinetics and pharmacodynamics trial in up to 220 healthy volunteers and patients |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomized controlled trial; randomized cross over trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| Scientific title | Phase I trial HMR code: 23-503 [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 23/01/2024, North East - York Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8052; york.rec@hra.nhs.uk), ref: 23/NE/0206 2. Approved 12/02/2024, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: - |
| 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 |
| 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 | 24/11/2023 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Healthy volunteer, Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 220 |
| Key inclusion 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. |
| 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 | 20/02/2024 |
| Date of final enrolment | 31/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
NW10 7EW
United Kingdom
Sponsor information
Industry
Steinmetz Building
Granta Park
Great Abington
Cambridge
CB21 6DG
England
United Kingdom
| Phone | +44 (0)1223 949 100 |
|---|---|
| reception@nxera.life |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/12/2028 |
|---|---|
| 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 1 study and the negligible benefit to the public of Phase I information. Results will 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
02/05/2024: Ethics approval details added. The contact, sponsor and funder fields were updated to change the company name from 'Heptares Therapeutics Limited' to 'Nxera Pharma UK Ltd'.
15/02/2024: Study's existence confirmed by the MHRA.
