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Clinical Trials in the USA / NCT06618183
Recruiting Observational

Drug Screening System Method Comparison

NCT06618183 · tracked via the Priya Life Science USA tracker
Sponsor
Intelligent Bio Solutions Inc.
Phase
Observational
Started
2024-08-26
Last updated
2024-10-01

Condition(s) studied

Reagent Kits, Diagnostic

Investigational drug(s) / intervention(s)

Fingerprint sweat drug screenFingerprint sweat laboratory analysis

Fingerprint sweat drug screen: Qualitative lateral-flow immunoassay analysis of fingerprint sweat specimen

Fingerprint sweat laboratory analysis: Laboratory analysis of fingerprint sweat specimen by liquid chromatography/tandem mass spectrometry

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. 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. 2. \*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. 3. Healthy male and non-pregnant female subjects from ages 18 to 65, inclusive, at the time of dosing. 4. \*Body mass index (BMI) from 18 kg/m2 to 30 kg/m2, inclusive, and weigh at least 60 kg. 5. \*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. 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. 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 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. \*Current severe hypotension (i.e., systolic blood pressure \<90 mmHg). 10. \*Reports known or suspected gastrointestinal obstruction including, paralytic ileus. 11. \*Reports current presence of acute bronchial asthma/ upper airway obstruction. 12. \*Reports a history of clinically significant allergies, including food or drug allergies, as judged by the Investigator. 13. \*Reports history or current condition of adrenal insufficiency. 14. \*Reports history or current condition of renal disease. 15. If, in the opinion of the Investigator, the subject is not suitable for the study. * Required only for \"donors.\" Not required for \"operators.\"

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
CenExel iResearch Decatur Georgia Recruiting
CenExel HRI Berlin New Jersey Recruiting
CenExel HRI Marlton New Jersey Recruiting

More Intelligent Bio Solutions Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06618183 on ClinicalTrials.gov ↗ ← All trials in the USA