A Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ENX-102 at Plasma Steady State in Healthy Volunteers
- Conditions
- Central nervous system disorders10042258
- Registration Number
- NL-OMON52117
- Lead Sponsor
- Engrail Therapeutics, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
- Healthy male and female volunteers aged 18 to 55 years, inclusive, at
Screening
- Capable of giving written informed consent
- Willing to give written consent to have data entered into Verified Clinical
Trials
- Female subjects
a. 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
b. 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
- Male subjects who, if fertile (defined as post pubertal and not permanently
sterile by orchidectomy or vasectomy) 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
- Body mass index of 18 to 35 kg/m2 at Screening
- Willing and able to comply with all study requirements including the
following:
a. Reside in the inpatient unit from Day -1 until discharge on Day 13
b. Refrain from strenuous exercise from Day -4 until Day 26
c. Abstain from grapefruit , alcohol , caffeine , or xanthine containing
products from Day -4 through Day 26
- Clinically significant abnormality within 2 years of Screening that in the
Investigator's opinion may place the subject at risk or interfere with
study outcome variables; this includes, but is not limited to, history of or
current cardiac, renal, neurologic, gastrointestinal, pulmonary,
endocrinologic, hematologic, or immunologic disease or history of malignancy
- Reports having experienced suicidal ideation (Type 4 or 5 on the CSSRS)
within 30 days prior to Screening, any suicidal behavior within 2
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
- History or evidence of moderate or severe Substance Use Disorder as defined
by the Diagnostic and Statistical Manual of Mental Disorders (5th Edition)
- Clinically significant abnormal findings in serum chemistry, coagulation,
hematology, or urinalysis results at Screening or Day -1
- Clinically significant abnormal findings in vital sign assessments at
Screening or Day -1
- History of hepatitis B or hepatitis C or demonstration of hepatitis B surface
antigen or hepatitis C antibody at Screening
- History of HIV infection or demonstration of HIV antibodies at Screening
- 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
- 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 <p>The safety and tolerability of ENX-102 will be assessed by the following:<br /><br>• AEs<br /><br>• Vital signs (2 positional blood pressure and HR, respiratory rate, and<br /><br>tympanic body temperature)<br /><br>• 12 lead ECG<br /><br>• Clinical laboratory tests (hematology, serum chemistry, urinalysis)<br /><br>• Physical examination<br /><br>• Pregnancy test (where applicable)<br /><br>• C SSRS<br /><br>• MOAA/S</p><br>
- Secondary Outcome Measures
Name Time Method