Actively Recruiting
Drug Screening System Method Comparison
Led by Intelligent Bio Solutions Inc. · Updated on 2024-10-01
135
Participants Needed
3
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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."
CONDITIONS
Official Title
Drug Screening System Method Comparison
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and sign informed consent written in English before dosing
- Completed screening within 30 days prior to dosing
- Healthy males and non-pregnant females aged 18 to 65 years
- Body mass index (BMI) between 18 and 30 kg/m2 and weight at least 60 kg
- Females of childbearing potential willing to use acceptable contraception and have a negative pregnancy test at study start
- Males willing to use acceptable contraception
- Judged to be in good health by medical history and vital signs, with any abnormalities deemed not clinically significant
You will not qualify if you...
- Unable or unwilling to provide informed consent
- Missing more than three digits on hands due to birth defect or injury
- Received investigational drug within 30 days prior to dosing
- Clinically significant illness within 30 days before the in-clinic study phase
- History of substance abuse or mental illness within one year prior to screening
- Pregnant females
- Clinically significant abnormal laboratory or vital signs results
- History of respiratory depression such as sleep apnea
- Current severe low blood pressure (systolic less than 90 mmHg)
- Known or suspected gastrointestinal obstruction including paralytic ileus
- Current acute bronchial asthma or upper airway obstruction
- History of significant allergies including food or drug allergies
- History or current adrenal insufficiency
- History or current kidney disease
- Determined unsuitable for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
CenExel iResearch
Decatur, Georgia, United States, 30030
Actively Recruiting
2
CenExel HRI
Berlin, New Jersey, United States, 08009
Actively Recruiting
3
CenExel HRI
Marlton, New Jersey, United States, 08053
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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