Phase I Trial: Quotient Code QSC301789
| ISRCTN | ISRCTN11217072 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11217072 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 1012766 |
| Protocol serial number | Sponsor Code LRK-4189-101 |
| Sponsor | Larkspur Biosciences |
| Funder | Larkspur Biosciences |
- Submission date
- 24/10/2025
- Registration date
- 24/10/2025
- Last edited
- 24/10/2025
- Recruitment status
- 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
Quotient Sciences Limited
Mere Way
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
| Phone | +44 (0) 330 303 1000 |
|---|---|
| recruitment@weneedyou.co.uk |
Public, Scientific
One Canal Park
Suite 210
Cambridge, Massachusetts
MA 02141
United States of America
| Phone | +1-617-693-1232 |
|---|---|
| trialinfo@larkspur.bio |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | First-in-man single ascending dose single-centre randomized study to assess the pharmacokinetics safety and tolerability in 48 healthy volunteers |
| Secondary study design | |
| Study type | Participant information sheet |
| Scientific title | Phase I Trial: Quotient Code QSC301789 [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) |
Submitted 26/08/2025, Wales REC 2 (Castlebridge 5, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 785738; wales.REC2@wales.nhs.uk), ref: 25/WA/0222 |
| 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) |
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. |
| Completion date | 24/04/2026 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target sample size at registration | 48 |
| 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 | 27/10/2025 |
| Date of final enrolment | 24/04/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Ruddington Fields
Ruddington
Nottingham
NG11 6JS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Not expected to be made available. |
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
24/10/2025: Study's existence confirmed by the Medicines and Healthcare products Regulatory Agency (MHRA), UK.
