Drug Screening System Method Comparison

Recruiting now

Conditions studied: Reagent Kits, Diagnostic

In brief

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

Key facts

Study ID

NCT06618183

Run by

Intelligent Bio Solutions Inc.

People needed

135

Starts

2024-08-26

Expected to finish

2024-12-31

Last updated by the study team

2024-10-01

Who can join

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

You may qualify if…

• Informed of the nature of the study, agreed to, and able to read, review, and sign the informed consent document prior to dosing. The informed consent document will be written in English; therefore, the subject must have the ability to read and communicate in English.
• *Completed the screening process within 30 days prior to dosing. Subjects screened as a part of an IRB-approved General Screening Protocol at the clinical research site may be included in this study without additional screening procedures, provided all the required screening procedures have been performed within 30 days prior to dosing.
• Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing.
• *Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg.
• *Females of childbearing potential must be willing to practice an acceptable form of contraception (see Section 9.3.3), 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.
• *Judged by the Investigator and/or designee to be in good health as documented by the medical history, and vital sign assessments. Any abnormalities or deviations outside the normal range for vital signs can be repeated by clinical staff and judged to be not clinically significant for study participation.

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).
• *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.
• Required only for \"donors.\" Not required for \"operators.\"

Where it is running

• CenExel iResearch — Decatur, Georgia, United States (enrolling)
• CenExel HRI — Berlin, New Jersey, United States (enrolling)
• CenExel HRI — Marlton, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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