Phase I trial HMR code: 25-001
| ISRCTN | ISRCTN11493807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11493807 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1011834 |
| Protocol serial number | HMR code: 25-001, Sponsor code: KMI-001/BIO |
| Sponsor | Dr Falk Pharma GmbH |
| Funder | Dr Falk Pharma GmbH |
- Submission date
- 09/05/2025
- Registration date
- 16/05/2025
- Last edited
- 31/07/2025
- 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
Hammersmith Medicines Research (HMR)
Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Public, Scientific
Leinenweberstr. 5
Freiburg
79108
Germany
| Phone | +49 (0)76115140 |
|---|---|
| phase1@drfalkpharma.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I safety, pharmacokinetics and pharmacodynamics trial in up to 84 healthy participants |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I trial HMR code: 25-001 [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 04/06/2025, London - Harrow Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8154; Harrow.rec@hra.nhs.uk), ref: 25/LO/0225 |
| 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 | 06/07/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 84 |
| Key inclusion criteria | Healthy human 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 | 03/06/2025 |
| Date of final enrolment | 06/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Park Royal
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
31/07/2025: The ethics approval was added.
16/05/2025: Trial's existence confirmed by MHRA.
