Phase I trial HMR code: 25-001
| ISRCTN | ISRCTN11493807 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11493807 |
| IRAS number | 1011834 |
| Secondary identifying numbers | HMR code: 25-001, Sponsor code: KMI-001/BIO |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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
Dr Adeep Puri
Principal Investigator
Principal Investigator
Hammersmith Medicines Research (HMR)
Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom
| Phone | +44 (0)20 8961 4130 |
|---|---|
| rec@hmrlondon.com |
Dr Ph1 Department
Public, Scientific
Public, Scientific
Leinenweberstr. 5
Freiburg
79108
Germany
| Phone | +49 (0)76115140 |
|---|---|
| phase1@drfalkpharma.de |
Study information
| Study design | Phase I safety, pharmacokinetics and pharmacodynamics trial in up to 84 healthy participants |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format. |
| 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 |
| 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 | 01/04/2025 |
| Completion date | 06/07/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Up to 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
- England
- United Kingdom
Study participating centre
Hammersmith Medicines Research (HMR)
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom
Park Royal
London
NW10 7EW
United Kingdom
Sponsor information
Dr Falk Pharma GmbH
Industry
Industry
Leinenweberstr. 5
Freiburg
79108
Germany
| Phone | +49 (0)76115140 |
|---|---|
| phase1@drfalkpharma.de |
Funders
Funder type
Industry
Dr Falk Pharma GmbH
No information available
Results and Publications
| Intention to publish date | 06/01/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 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. |
| 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
31/07/2025: The ethics approval was added.
16/05/2025: Trial's existence confirmed by MHRA.
