ENX-102 is a new research drug that is being developed for the treatment of neuropsychiatric disorders. Nervous System Diseases
Conditions
Interventions
This is a randomized, double blind, placebo controlled, multiple ascending dose study in healthy volunteers. Subjects will be screened within 28 days of Day 1. Eligible subjects will be admitted to th
discharge will be contingent upon clinical assessment and judgment of the Investigator. The 14 day inpatient period includes a 1-day Baseline Period (Day 1), a 12 day Treatment Period (Day 1 through
Sponsors
Engrail Therapeutics, Inc
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female volunteers aged 18 to 55 years, inclusive, at Screening 2. Capable of giving written informed consent 3. Willing to give written consent to have data entered into "Verified Clinical Trials" 4. Female subjects 4.1. Of non childbearing potential, defined as either permanently sterilized (at least 4 months after surgical sterilization including bilateral salpingectomy, tubal ligation, or oophorectomy with or without hysterectomy) or post menopausal (defined as amenorrhea for 12 consecutive months and documented plasma follicle stimulating hormone level >40 IU/mL; in the event a subject's menopausal status has been clearly established and yet serum follicle stimulating hormone levels are not consistent with a post menopausal status, determination of the subject's eligibility to be included in the study will be at the Investigator's discretion following consultation with the Sponsor), and with a negative pregnancy test at Screening and Day –1; OR 4.2. Of childbearing potential and willing to use 2 effective methods of contraception (i.e., established method of contraception + condom) or remain abstinent (where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day –1 through 3 months after the last dose of study drug, and with a negative pregnancy test at Screening and Day –1 5. Male subjects who, if fertile (defined as post pubertal and not permanently sterile by orchidectomy or vasectomy) 6. must be willing to use a condom or remain abstinent (where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from Day –1 through 3 months after the last dose of study drug 7. Body mass index of 18 to 35 kg/m² at Screening 8. Willing and able to comply with all study requirements including the following: 8.1. Reside in the inpatient unit from Day –1 until discharge on Day 13 8.2. Refrain from strenuous exercise from Day –4 until Day 26 8.3. Abstain from grapefruit, alcohol, caffeine, or xanthine containing products from Day –4 through Day 26
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with 2. study outcome variables; this includes, but is not limited to, history of or current cardiac, renal, neurologic, gastrointestinal, pulmonary, 3. endocrinologic, hematologic, or immunologic disease or history of malignancy 4. Reports having experienced suicidal ideation (Type 4 or 5 on the CSSRS) within 30 days prior to Screening, any suicidal behavior within 2 5. years prior to Screening (any "Yes" answers on Suicidal Behavior section of C-SSRS), and/or the Investigator assesses the subject to be a safety risk to him/herself or others 6. History or evidence of moderate or severe Substance Use Disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) 7. Clinically significant abnormal findings in serum chemistry, coagulation, hematology, or urinalysis results at Screening or Day –1 8. Clinically significant abnormal findings in vital sign assessments at Screening or Day –1 9. History of hepatitis B or hepatitis C or demonstration of hepatitis B surface antigen or hepatitis C antibody at Screening 10. History of HIV infection or demonstration of HIV antibodies at Screening 11. Receipt of an investigational drug within 90 days or 5 half-lives, whichever is longer, prior to Day 1 or currently in the follow-up period of another clinical trial at the time of Screening 12. Any other condition that, in the Investigator's opinion, might indicate that the subject is unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of ENX-102 will be assessed by the following: 1. AEs (day 1 to day 26) measured using patient records 2. Vital signs (2 positional blood pressure and HR, respiratory rate, and tympanic body temperature) at screening, day -1 to day 13, day 19 day 26 3. 12 lead ECG at screening, day -1, day 1, day 12, day 13, day 26 4. Clinical laboratory tests (hematology, serum chemistry, urinalysis) at screening, day -1, day 6, day 13, day 26 5. Physical examination at screening, day -1, day 13, day 26 6. Pregnancy test (where applicable) 7. C SSRS at screening, day -1, day 1, day 6, day 13, day 26 8. MOAA/S at day 1, day 2, day 12, day 13, day 19, day 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Measures at Day 1: Pre-dose and at 0.5, 1, 1.5, 2, 3, 6, 8, 10, and 12 hours after dosing; Days 2-11: Pre-dose (24 hours after the previous day’s dose); Day 12: Pre-dose (24 hours after Day 13 dosing) and at 0.5, 1, 1.5, 2, 3, 6, 8, 10, and 12 hours after dosing; Days 13: 24 hours after Day 12 dosing; Day 19: 168 hours after Day 12 dosing; Day 26: 312 hours after Day 12 dosing: 1. Maximum plasma concentration (Cmax) 2. Time to reach maximum plasma concentration (Tmax) 3. Area under the plasma concentration time curve (AUC) from administration to the end of dosing (AUC0 t), 4. AUC from administration to 24 h after dosing (AUC0 24), AUC extrapolated to infinite time (AUC0 8), 5. Plasma concentration half life (t1/2), 6. Terminal rate constant (?z), 7. Apparent total clearance of the drug from plasma after oral administration (CL/F), 8. Apparent volume of distribution during terminal phase after non intravenous administration (Vz/F). Pharmacodynamic Measures at Baseline, Single dose (Day 1), Steady state (Day 12): NeuroCart assessments 1. Saccadic eye movements, saccadic reaction time (seconds), saccadic peak velocity (degrees/second), and saccadic inaccuracy (%) 2. Smooth pursuit eye movements (percentage of time the eyes of the subject are in smooth pursuit of the target) (%) 3. Adaptive tracking (average performance) (%) 4. Body sway (antero posterior sway) (mm) 5. Pupil size 6. VAS according to Bond and Lader to assess mood, alertness, and calmness (mm) 7. Cognitive assessment: VVLT (Learning and Immediate Recall, Delayed Recall, and Delayed Recognition) 8. qEEG | — |
Countries
Netherlands
Contacts
Public ContactPauline Nettesheim
Outcome results
None listed