Deferred registration: NRG5051-102
| ISRCTN | ISRCTN15580445 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15580445 |
| Integrated Research Application System (IRAS) | 1014055 |
| Parexel study code | 297147 |
| Sponsor | NRG Therapeutics Ltd |
| Funder | NRG Therapeutics Ltd |
- Submission date
- 18/08/2026
- Registration date
- 20/08/2026
- Last edited
- 20/08/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date
Contact information
Dr Tunde Adebayo
Principal investigator, Public, Scientific
Principal investigator, Public, Scientific
Parexel EPCU, Level 7, Northwick Park Hospital, Watford Road, Harrow
London
HA1 3UJ
United Kingdom
| Phone | +44 1895 694883 |
|---|---|
| harrowvolunteerfeedback@parexel.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | biodistribution assessment, safety |
| Scientific title | Deferred registration: NRG5051-102 [Full scientific/public title to be added on or before the deferral expiry date] |
| Study objectives | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Ethics approval(s) |
Approved 16/07/2026, London Brent Research Ethics Committee (REC) (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; no telephone number provided; brent.rec@hra.nhs.uk), ref: 26/LO/0351 |
| Health condition(s) or problem(s) studied | Assessment of blood/brain distribution of an IMP for Neurodegenerative Disease, specifically ALS (Amyotrophic Lateral Sclerosis) in healthy adults |
| Intervention | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 8 |
| Key inclusion criteria | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Key exclusion criteria | This is a phase I trial in healthy volunteers only and qualifies for an automatic deferral. The full details will be added to the trial record on or before the deferral expiry date |
| Date of first enrolment | 04/08/2026 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Parexel EPCU (Early Phase Clinical Unit)
Parexel, Level 7, Northwick Park Hospital, Watford Road, Harrow
London
HA1 3UJ
England
London
HA1 3UJ
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
19/08/2026: Trial's existence confirmed by NHS HRA.
