Recruiting

Observational Study

Sponsor:

Intelligent Bio Solutions Inc.

Code:

NCT07650136

Conditions

Drug Abuse Illicit

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

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."

Conditions

Drug Abuse Illicit

Study ID

NCT07650136

Start date

Jun 2, 2026

Status verified date

Jul, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

144 participants

Anticipated

Interventions and Outcome Measures

Arms

Undosed

No codeine administered

Dosed

2 doses of codeine administered in tablet form, 60 mg per dose

Primary outcome measure

  • Sensitivity [ Time Frame: 24 hrs ]
  • Specificity [ Time Frame: 24 hrs ]
  • Accuracy [ Time Frame: 24 hrs ]

Central Contacts and Locations

Central contacts

Locations

CenExel Clinical Research

Recruiting

Marlton, New Jersey, United States, 08053

More Information

Sponsor

Intelligent Bio Solutions Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Intelligent Bio Solutions Inc. on 2026-08-03.