Phase I Study: QSC301634
| ISRCTN | ISRCTN14571405 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14571405 |
| Integrated Research Application System (IRAS) | 1009011 |
| CRO Study Code | QSC301634 |
| Sponsor | Evecxia Therapeutics, Inc. |
| Funder | Evecxia Therapeutics, Inc. |
- Submission date
- 16/03/2026
- Registration date
- 17/03/2026
- Last edited
- 17/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Deferred
- Condition category
- Other
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
Principal investigator
Mere Way, Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0)1159749000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
2 Davis Drive
RTP
NC
27709
United States of America
| Phone | +1 (919) 597-8762 |
|---|---|
| info@evecxia.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Active |
| Assignment | Crossover |
| Purpose | Phase I study in healthy volunteers |
| Scientific title | Phase I Trial: QSC301634 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 25/02/2026, London - Brent Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8137; brent.rec@hra.nhs.uk), ref: 26/LO/0013 |
| Health condition(s) or problem(s) studied | 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 | 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 |
| 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(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. |
| Key secondary outcome measure(s) | |
| Completion date | 16/05/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 28 |
| Key inclusion 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. |
| 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 | 31/03/2026 |
| Date of final enrolment | 16/05/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington
Nottingham
NG11 6JS
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
16/03/2026: Study's existence confirmed by the MHRA.
