Phase I trial: Celerion code CA33748

ISRCTN	ISRCTN68610794
DOI	https://doi.org/10.1186/ISRCTN68610794
EudraCT/CTIS number	2021-004177-32
IRAS number	1004078
Secondary identifying numbers	IRAS 1004078; Celerion code: CA33748

Submission date: 07/01/2025
Registration date: 13/01/2025
Last edited: 13/01/2025

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 30 months after the trial has ended.

Contact information

Dr Nadine Abdullah
Principal Investigator

22-24 Lisburn Road
Belfast
BT9 6AD
United Kingdom

ORCID ID	0000-0001-7772-7724
Phone	+44289055 4000
Email	nadine.abdullah@celerion.com

Dr Akhilesh Shama
Scientific

Alkem House, Devashish, Adjacent to Matulya Centre, Senapati Bapat, Marg, Lower Parel
Mumbai
400 013
India

Phone	+9122 39829999
Email	akhilesh.sharma@alkem.com

Dr Vinayaka Shahavi
Public

Alkem House, Devashish, Adjacent to Matulya Centre, Senapati Bapat, Marg, Lower Parel
Mumbai
400 013
India

Phone	+9122 39829999
Email	vinayaka.shahavi@alkem.com

Study information

Study design	Pharmacokinetic pharmacodynamic safety and tolerability study in 189 healthy adult volunteers
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Pharmaceutical testing facility
Study type	Safety, Efficacy
Participant information sheet	Not available in web format
Scientific title	Phase I trial: Celerion code CA33748
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)	Approved 14/12/2021, London - Harrow Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, United Kingdom; +44 (0)207 104 8137; harrow.rec@hra.nhs.uk), ref: 21/LO/0838
Health condition(s) or problem(s) studied	Healthy volunteers
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
Pharmaceutical study type(s)	Pharmacokinetic, Pharmacodynamic
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 30 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 30 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 30 months after the trial has ended.
Overall study start date	19/10/2021
Completion date	22/05/2024

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target number of participants	189
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	10/01/2022
Date of final enrolment	30/08/2023

Locations

Countries of recruitment

Bulgaria
England
Northern Ireland
Poland
United Kingdom

Study participating centres

Celerion GB Limited

Suite 1, 7th Floor 50 Broadway
London
SW1H 0BL
United Kingdom

MTZ Clinical Research powered by Pratia

Pratia S.A., Gladka 22
Warszawa
02-172
Poland

COMAC

3 Sv. Georgi Sofiyski str./13 Urvich str.
Sofia
1606/1612
Bulgaria

Sponsor information

Alkem (India)
Industry

Alkem House, Devashish, Adjacent to Matulya Centre, Senapati Bapat, Marg, Lower Parel
Mumbai
400 013
India

Phone	+9122 39829999
Email	akhilesh.sharma@alkem.com
Website	https://www.alkemlabs.com/
"ROR"	https://ror.org/04kwy9224

Enzene BioSciences Ltd.
Industry

165/1/26, Block-T, Bhosari MIDC, PCMC
Pune
411026
India

Phone	+9120 30674622
Email	harish.shandilya@enzene.com
Website	https://www.enzene.com/

Funders

Funder type

Industry

Alkem Laboratories Ltd.

No information available

Results and Publications

Intention to publish date	22/11/2026
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. The full details will be added to the study record within 30 months after the trial has ended. Publication of some trial details is deferred because of the high commercial sensitivity of this Phase I study and the negligible benefit to the public of Phase I information. Results may be posted on or after the date of publication of full trial details.
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to the protection of commercially confidential information.

Editorial Notes

08/01/2025: Study's existence confirmed by Health Research Authority (HRA) (UK).