Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy… (NCT06595706) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Safety and Pharmacokinetics of Multiple Ascending Doses of Lucid-21-302 in Healthy Adult Participants
Australia16 participantsStarted 2024-09-28
Plain-language summary
This study aims to determine the safety and pharmacokinetics of multiple ascending doses of Lucid-21-302 in healthy adult participants.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female, aged ≥18 and ≤60 years (inclusive), with BMI \>18.0 and \<32.0 kg/m2 and body weight ≥50.0 kg. Social smokers consuming less than 10 cigarettes per week, with a negative cotinine test at screening and Day -1 will be allowed.
✓. Participant is judged by the Investigator to be in generally good health on the basis of medical history, physical examination, or clinical laboratory results during the screening.
✓. Pulse between 45 and 100 beats per minute (bpm) in supine position at screening (inclusive)
✓. Supine systolic BP between 90 and 160 mmHg, diastolic BP between 50 and 95 mmHg inclusive, at screening. For the purpose of qualifying any given participant for study participation, out-of-range vital signs may be repeated once.
✓. Ability to consume standard meals and the ability to fast for at least ten hours.
✓. Agree not to have a tattoo or body piercing until the end of the study.
✓. Agree not to receive the COVID-19 vaccination or other vaccination from seven days prior to the study drug dose until seven days after study drug administration in the study.
✓. Must not be pregnant, breastfeeding (non-lactating), or planning pregnancy.
Exclusion criteria
✕. History of any clinically significant gastrointestinal, renal, hepatic (except cholecystectomy), neurologic, hematologic, endocrine, oncologic, pulmonary (except resolved childhood astma), immunologic, or cardiovascular disease or other condition which would jeopardize safety or impact validity of results (in the opinion the Investigator); history of common medical conditions such as depression (non-hospitalised, but potentially medicated in the past), migraine or Gilbert syndrome will not be allowed unless the exemption will be provided by the Investigator.
✕. Participant has any documented clinically significant infection, injury, or illness within 1 month prior to screening.
✕. Participant has any documented history of, or currently active, seizure disorder (any seizure including infantile seizures), or history of clinically significant head injury based on the opinion of the Investigator.
✕. Participants who have a history of surgery within 6 months prior to screening, or who have a plan of surgery during the study. Small surgeries such as dental operation, biopsies and non-invasive surgeries may be allowed at Investigator discretion.
✕. Liver function test results elevated more than 1.5-fold above the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants; Testing for any out-of-range values may be repeated once at the discretion of the Investigator.
✕. A calculated creatinine clearance of \< 60 mL/minute at Screening according to the equation using Cockcroft and Gault.
✕. Participant has an active malignancy of any type or has been diagnosed with cancer within 5 years prior to screening (excluding squamous or basal cell carcinoma of the skin).
What they're measuring
1
Incidence, severity and relationship of Adverse Events (AEs)
Timeframe: Up to 15 days
2
Incidence of Serious AEs (SAEs) and suspected unexpected SAEs
Timeframe: Up to 15 days
3
Number of discontinuations due to AEs
Timeframe: Up to 15 days
4
Clinically significant changes from baseline in complete blood count
Timeframe: Up to 15 days
5
Clinically significant changes from baseline in blood coagulation
Timeframe: Up to 15 days
6
Clinically significant changes from baseline in blood biochemistry
Timeframe: Up to 15 days
7
Clinically significant changes from baseline in urinalysis
Timeframe: Up to 15 days
8
Clinically significant changes from baseline in physical exam
. Any laboratory test results deemed clinically significant by the Investigator or positive test serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody at screening.
9
Clinically significant changes from baseline in systolic blood pressure
Timeframe: Up to 15 days
10
Clinically significant changes from baseline in diastolic blood pressure
Timeframe: Up to 15 days
11
Clinically significant changes from baseline in heart rate
Timeframe: Up to 15 days
12
Clinically significant changes from baseline in respiratory rate
Timeframe: Up to 15 days
13
Clinically significant changes from baseline in tympanic temperature
Timeframe: Up to 15 days
14
Clinically significant changes from baseline in 12-lead electrocardiogram (ECG)
Timeframe: Up to 15 days
15
Clinically significant changes from baseline in patient health questionnaire (PHQ-9)
Timeframe: Up to 15 days
16
Clinically significant changes from baseline in generalized anxiety disorder questionnaire (GAD7)
Timeframe: Up to 15 days
17
Clinically significant changes from baseline in Columbia suicide severity rating scale (C-SSRS)
Timeframe: Up to 15 days
18
Clinically significant changes from baseline in neurological exam