Drug Screening System Method Comparison
User Performance Evaluation of the Intelligent Fingerprinting Drug Screening System: Method Comparison and Usability
Intelligent Bio Solutions Inc.
135 participants
Aug 26, 2024
OBSERVATIONAL
Conditions
Summary
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."
Eligibility
Inclusion Criteria7
- 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.
Exclusion Criteria16
- 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.\"
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen
Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06618183