Method Comparison of Intelligent Fingerprinting Drug Screening System

User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison

Prospective, multi-site, open-label, single- or double-dose, randomized, multi-site performance evaluation of accuracy of the Intelligent Fingerprinting Drug Screening System in the hands of intended users: "operators" and "donors."

Study Overview

• Status: Recruiting
• Conditions: In Vitro Diagnostic Device
• Intervention / Treatment: Device: Diagnostic Test

Detailed Description

This will be a study under non-fasting conditions. The total number of healthy adult "operator" subjects (male and non-pregnant females) required for enrollment in this study protocol is nine (9). The total number of healthy adult "donor" subjects (male and non-pregnant females) required for enrollment in this study protocol is 135. These subjects will be distributed across three sites with the recruiting goal of three (3) operators and 45 subjects per site.

Subjects will be recruited to participate as either "operator" or "donor." The total duration of the study, from check-in through the end of the study will be approximately three (3) days for "operators" with no overnight confinement, and one to eight hours for "donors" at two of the sites. At the third site, 31 "donors" will be dosed twice and will remain at the clinic overnight so that biological sampling can occur 24 hours after the first codeine dose. Because the "operators" are required to be at the clinic for three days, they may be recruited separately and compensated at a different rate than the "donors." "Operators" may be employed by the clinic.

"Donors" at sites 1 and 2 will be block randomized to one of two cohorts: no codeine dose or 60 mg codeine dose. The goal is to complete the study with approximately 69% of subjects in the 60 mg cohort. "Donors" at site 3 will be randomized into one of two cohorts: no codeine dose or two 60 mg doses. The cohort receiving two 60 mg codeine doses will be confined at the clinic overnight to enable additional biological sampling events.

• Study Type: Observational
• Enrollment (Estimated): 144

Contacts and Locations

• Study Contact: Name: Elan Cohen, PhD; Phone Number: 856.452.9901; Email: e.cohen@cenexel.com

Study Locations

• United States
  • New Jersey
    • Marlton, New Jersey, United States, 08053
      • Recruiting
      • CenExel Clinical Research
      • Contact: Elan Cohen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

135 "donors" and nine "operators." "Operators" represent end users who utilize the screening system in an office or work setting. These subjects do not have to possess special training in laboratory methods. "Donors" represent end users either applying for employment or working at an organization that conducts pre-employment and/or periodic workplace drug screening.

Sufficient numbers of subjects will be screened to attain those numbers and to ensure that at least 33% of each sex and at least 15% Black subjects are included as "donors" in the study. At least two sites will have both sexes represented among "operator" subjects. Sites may recruit sufficient alternate subjects to ensure achievement of those numbers.

Subjects will be selected from members of the community at large.

Description

Inclusion Criteria:

1. Able to provide informed consent 2. Completed the screening process within 30 days prior to dosing. 3. Healthy male and non-pregnant female subjects at the time of dosing. 4. Body mass index (BMI) from 18.0 kg/m2 to 32.0 kg/m2, inclusive 5. Weigh at least 60 kg. 5. Females of childbearing potential must be willing to practice an acceptable form of contraception, and have a negative urine pregnancy test on admission to the treatment phase of the study.

6. Males must agree to practice an acceptable form of contraception 7. Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments.

Exclusion Criteria:

1. Unwilling or unable to provide informed consent.
2. More than three digits absent from the hands due to congenital or accidental cause(s).
3. Reports receiving any investigational drug within 30 days prior to dosing.
4. Reports a clinically significant illness during the 30 days prior to the in-clinic portion of the study (as determined by the Investigator).
5. Reports any personal history of substance abuse (including drug/alcohol abuse or addiction) or mental illness (e.g. major depression) within one year prior to screening visit.
6. Is pregnant (females only).
7. Presence of any clinically significant results from laboratory tests and vital signs assessments, as judged by the Investigator.
8. Reports history of respiratory depression (e.g., sleep apnea).
9. Reports history of reaction to codeine (e.g., nausea, allergy).
10. Current severe hypotension (i.e., systolic blood pressure <90 mmHg).
11. Reports known or suspected gastrointestinal obstruction including, paralytic ileus.
12. Reports current presence of acute bronchial asthma/ upper airway obstruction.
13. Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator.
14. Reports history or current condition of adrenal insufficiency.
15. Reports history or current condition of renal disease.
16. If, in the opinion of the Investigator, the subject is not suitable for the study.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Undosed; No codeine administered	Device: Diagnostic Test; Measurement of codeine in human fingerprint sweat
Dosed; 2 doses of codeine administered in tablet form, 60 mg per dose	Device: Diagnostic Test; Measurement of codeine in human fingerprint sweat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine	24 hrs
Specificity	Specificity of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine	24 hrs
Accuracy	Accuracy of the Intelligent Fingerprinting DSC 7-Plus Drug Screening Cartridge for Codeine	24 hrs

Collaborators and Investigators

• Sponsor: Intelligent Bio Solutions Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Tests, Routine
• Other Study ID Numbers: IBS-2025-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No