Phase I trial BDD code: BDD22320

ISRCTN	ISRCTN17405388
DOI	https://doi.org/10.1186/ISRCTN17405388
IRAS number	1009022
Secondary identifying numbers	MOS118-101

Submission date: 24/07/2025
Registration date: 24/07/2025
Last edited: 24/07/2025

Recruitment status: No longer 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 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 12 months after the trial has ended.

Contact information

Dr Lyn Corry
Public, Scientific, Principal Investigator

BDD Pharma Ltd
Within Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

ORCID ID	0009-0008-4224-4667
Phone	0141 552 8791
Email	Lyn.Corry@bddpharma.com

Study information

Study design	Pharmacoscintigraphic open-label crossover study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Other
Study type	Other
Scientific title	Phase I trial BDD code: BDD22320
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 12 months after the trial has ended.
Ethics approval(s)	Approved 04/03/2024, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)2071048128; brent.rec@hra.nhs.uk), ref: 24/LO/0003
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 12 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 12 months after the trial has ended.
Intervention type	Drug
Pharmaceutical study type(s)	Pharmacokinetic, Scintigraphy
Phase	Phase I
Drug / device / biological / vaccine name(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 12 months after the trial has ended.
Primary outcome measure	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 12 months after the trial has ended.
Secondary outcome measures	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 12 months after the trial has ended.
Overall study start date	01/09/2023
Completion date	18/08/2025

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	8
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 12 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 12 months after the trial has ended.
Date of first enrolment	09/06/2025
Date of final enrolment	23/06/2025

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

BDD Pharma Ltd

Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

Sponsor information

Mosanna Therapeutics
Industry

c/o Walder Wyss AG
Aeschenvorstadt 48
Basel
4051
Switzerland

Phone	+1 (650) 381-9916
Email	info@mosanna.com
Website	https://mosanna.com/

Funders

Funder type

Industry

Mosanna Therapeutics

No information available

Results and Publications

Intention to publish date	18/08/2026
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The Health Research Authority (HRA) has approved deferral of publication of the full details of the trial because of the high commercial sensitivity of this phase I study. Results will be posted on or after the date of publication of full trial details.
IPD sharing plan	The datasets generated and/or analysed during the study are not expected to be made available because of the high commercial sensitivity of this phase I study and the negligible benefit to the public of phase I information.

Editorial Notes

24/07/2025: Study's existence confirmed by Health Research Authority (HRA) (UK).