Study to investigate the effects and safety of ENX-102 in healthy volunteers.
- Conditions
- ENX-102 is a new research drug that is being developed for the treatment of neuropsychiatric disorders.Nervous System Diseases
- Registration Number
- ISRCTN61386931
- Lead Sponsor
- Engrail Therapeutics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> The safety and tolerability of ENX-102 will be assessed by the following:<br> 1. AEs (day 1 to day 26) measured using patient records<br> 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<br> 3. 12 lead ECG at screening, day -1, day 1, day 12, day 13, day 26<br> 4. Clinical laboratory tests (hematology, serum chemistry, urinalysis) at screening, day -1, day 6, day 13, day 26<br> 5. Physical examination at screening, day -1, day 13, day 26<br> 6. Pregnancy test (where applicable)<br> 7. C SSRS at screening, day -1, day 1, day 6, day 13, day 26<br> 8. MOAA/S at day 1, day 2, day 12, day 13, day 19, day 26<br>
- Secondary Outcome Measures
Name Time Method