Phase I trial: Celerion code CA33748

ISRCTN	ISRCTN68610794
DOI	https://doi.org/10.1186/ISRCTN68610794
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	2021-004177-32
Integrated Research Application System (IRAS)	1004078
Protocol serial number	IRAS 1004078; Celerion code: CA33748
Sponsors	Alkem (India), Enzene BioSciences Ltd.
Funder	Alkem Laboratories Ltd.

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

Primary study design	Interventional
Study design	Pharmacokinetic pharmacodynamic safety and tolerability study in 189 healthy adult volunteers
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
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
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(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.
Key secondary outcome measure(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.
Completion date	22/05/2024

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Sex	Male
Target sample size at registration	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

United Kingdom
England
Northern Ireland
Bulgaria
Poland

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

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 during and/or analysed during the current study are not expected to be made available due to the protection of commercially confidential information.

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

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