Method Comparison of Intelligent Fingerprinting Drug Screening System

Recruiting now

Conditions studied: Drug Abuse Illicit

In brief

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."

Key facts

Study ID

NCT07650136

Run by

Intelligent Bio Solutions Inc.

People needed

144

Starts

2026-06-02

Expected to finish

2026-08-31

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

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

Where it is running

• CenExel Clinical Research — Marlton, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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