N.1
CLINICAL STUDIES
Current Clinical Studies
Our ongoing/approved clinical studies are listed below. All studies have been approved by IRB, DSRB, or ethics boards based at the specified study sites.
Please contact our Clinical/Translational Team for more information. Please note that some trials are currently being conducted at international sites only. When local approval is obtained, the information on this page will be updated.
UPDATE (29.10.18): N.1 is currently preparing for the approvals of new human studies pertaining to neuroengineering and hematologic oncology. In addition, filings to expand existing studies to local sites have been made. Please check back for updates.
THERANOSTIC DEVICES
N.1 Investigators are currently conducting an interventional study pertaining to the use of a device to reduce chemotherapy-induced peripheral neuropathy (National University Hospital/NUH)
Active study: Clinicaltrials.gov: NCT03248193
Completed study: Clinicaltrials.gov: NCT03299582
ARTIFICIAL INTELLIGENCE: CURATE.AI
CURATE.AI: Digital Therapeutics
The initiation of a trial to harness digital therapy to prevent cognitive decline in patients who have had whole-brain radiation is pending. Please check back for updates.
CURATE.AI: Solid Cancer Therapy
The initiation of a trial to optimise therapy for solid cancer patients is pending. Please check back for updates.
***UPDATE***
CURATE.AI: MM
We have received approval to conduct a prospective interventional study (NCT Phase 2/3-equivalent) pertaining to CURATE.AI-driven optimisation of multiple myeloma combination therapy. This is a N-of-1 clinical trial, with an estimated 20 subjects being recruited. This study will take place at National University Hospital (NUH)/National University Cancer Institute (NCIS). Interested parties should contact Mr. Theodore Kee (bietwk AT nus.edu.sg). More information can also be found at: Clinicaltrials.gov: NCT03759093.
CURATE.AI: GC
We have received approval to conduct a prospective expanded access interventional study pertaining to CURATE.AI-driven optimisation of gastric cancer combination therapy (metastatic/advanced). This is a N-of-1 clinical trial and is not currently recruiting additional patients (In collaboration with Tan Tock Seng Hospital). Interested parties should contact Mr. Theodore Kee (bietwk AT nus.edu.sg).
This trial is currently underway. Results are pending.
CURATE.AI: MCRPC
We are currently conducting a prospective, first-in-human interventional study pertaining to CURATE.AI-driven optimisation of solid tumor combination therapy (metastatic/advanced). This is a N-of-1 clinical trial and is not currently recruiting additional patients.
Note: This patient provided written informed consent to participate in a nonrandomized, open label, phase 1b/2a clinical trial (ClinicalTrials.gov: NCT02711956, US site).
Results for this study are pending.
CURATE.AI: LT
N.1 Labs is currently conducting a prospective, expanded access first-in-human interventional study pertaining to CURATE.AI-driven optimisation of solid tumor combination therapy (metastatic/advanced). This is a N-of-1 clinical trial and is not currently recruiting additional patients (Taiwan site).
CURATE.AI: TM-L
N:1 Labs is currently conducting a prospective interventional study pertaining to CURATE.AI-driven optimisation of post-transplant immunosuppression. This is a N-of-1 clinical trial and patient recruitment is pending (Clinicaltrials.gov: NCT03527238, US site)
Results from the first-in-human study can be found in Science Translational Medicine, 333ra49, 2016 http://stm.sciencemag.org/content/8/333/333ra49
N-of-1 Multitasking Training
N-of-1 Training Trajectories
N.1 announces the registration of a new N-of-1 interventional human study on multitasking training (Clinicaltrials.gov: NCT03832101; PI: Dr. Christopher Asplund). The study estimates the enrollment of up to 100 subjects (Clinicaltrials.gov: NCT03832101, NUS site.)
Digital Health
Mental Health: Digital Para-counseling
The initiation of a study to harness a digital para-counseling platform for mental health is pending. Please check back for updates regarding recruitment and our study partner.
NANOMEDICINE
NDGP (Nano 1)
We have received approval to initiate clinical studies to validate Nanodiamond-Gutta Percha (NDGP) as a non-surgical root canal biomaterial (Clinicaltrials.gov: NCT02698163, US site).
Results from the first-in-human study can be found in PNAS, E9445, 2017 http://www.pnas.org/content/114/45/E9445
GPx (Nano 2)
We have received approval to initiate clinical studies to validate a therapeutic-Nanodiamond-GP (GPx) device (Clinicaltrials.gov: NCT03376984, US site).