Phase I trial: Parexel code: PXL 269850
| ISRCTN | ISRCTN12117857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12117857 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | 2022-003322-50 |
| Integrated Research Application System (IRAS) | 1006840 |
| Protocol serial number | IRAS 1006840, PXL 269850, NMD1343-01-0001 |
| Sponsor | NMD Pharma |
| Funder | NMD Pharma |
- Submission date
- 29/06/2023
- Registration date
- 29/06/2023
- Last edited
- 30/04/2025
- Recruitment status
- No longer 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
Parexel Early Phase Clinical Unit
Harrow
HA1 3UJ
United Kingdom
| Phone | +44 (0)7548098654 |
|---|---|
| david.steel@parexel.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I first-in-human study to assess safety, tolerability and pharmacokinetics in healthy volunteers |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial: Parexel code: PXL 269850 [The full scientific title will be published within 30 months after the end of the trial] |
| 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) |
1. Approved 09/02/2023, London - Harrow Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom; +44 (0)207 104 8154; harrow.rec@hra.nhs.uk), ref: 23/LO/0007 2. Approved 21/02/2023, MHRA (10 South Colonnade, Canary Wharf, London, E14 4PU, United Kingdom; +44 (0)20 3080 6000; info@mhra.gov.uk), ref: CTA 57479/0001/001-0001 |
| 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 |
| 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 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 secondary outcome measure(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. |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 88 |
| 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 | 21/03/2023 |
| Date of final enrolment | 30/04/2024 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Watford Road
Harrow
HA1 3UJ
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 during and/or analysed during the current study are not expected to be made available due to the study being conducted in healthy volunteers |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 20/09/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/04/2025: EudraCT/CTIS number and a secondary identifying number were added.
20/09/2023: A link to the HRA research summary was added.
29/06/2023: Study's existence confirmed by the MHRA.
