ISRCTN ISRCTN11493807
DOI https://doi.org/10.1186/ISRCTN11493807
IRAS number 1011834
Secondary identifying numbers IRAS 1011834, HMR code: 25-001, Sponsor code: KMI-001/BIO
Submission date
09/05/2025
Registration date
16/05/2025
Last edited
16/05/2025
Recruitment status
Not yet 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

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

Hammersmith Medicines Research (HMR)
Cumberland Avenue, Park Royal
London
NW10 7EW
United Kingdom

Phone +44 (0)20 8961 4130
Email rec@hmrlondon.com
Dr Ph1 Department
Public, Scientific

Leinenweberstr. 5
Freiburg
79108
Germany

Phone +49 (0)76115140
Email phase1@drfalkpharma.de

Study information

Study designPhase I safety, pharmacokinetics and pharmacodynamics trial in up to 84 healthy participants
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeOther
Participant information sheet Not available in web format.
Scientific titlePhase I trial HMR code: 25-001 [The full scientific title will be published within 30 months after the end of the trial]
Study hypothesisThe 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)

Submitted 01/04/2025, 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

ConditionHealthy volunteers
InterventionThe 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 typeDrug
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.
PhasePhase 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 measureThe 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 measuresThe 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 date01/04/2025
Overall study end date06/07/2026

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participantsUp to 84
Participant inclusion criteriaHealthy human volunteer
Participant exclusion criteriaThe 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.
Recruitment start date03/06/2025
Recruitment end date06/04/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hammersmith Medicines Research (HMR)
Cumberland Avenue
Park Royal
London
NW10 7EW
United Kingdom

Sponsor information

Dr Falk Pharma GmbH
Industry

Leinenweberstr. 5
Freiburg
79108
Germany

Phone +49 (0)76115140
Email phase1@drfalkpharma.de

Funders

Funder type

Industry

Dr Falk Pharma GmbH

No information available

Results and Publications

Intention to publish date06/01/2029
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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 planThe 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

16/05/2025: Trial's existence confirmed by MHRA.