Assessment of [18F]MNI-1054 as a Marker for LSD1

The primary objective of this protocol is to evaluate [18F]MNI-1054 as a Lysine-specific
histone demethylase 1A (LSD1) enzyme targeted radiopharmaceutical. The specific objectives
are:

- To measure the dynamic uptake and washout of [18F]MNI-1054 in brain using positron
emission tomography (PET) in healthy volunteers.

- To measure blood metabolites of [18F]MNI-1054 in the healthy volunteers and to perform
invasive as well as non-invasive modeling to assess its ability to measure LSD1 in the
brain.

- To acquire safety data following injection of [18F]MNI-1054

- Evaluation of [18F]MNI-1054 PET reliability (test/retest) of the tracer parameters in
healthy volunteers.

Inclusion Criteria:

- Understand the study procedures and agree to participate by providing written informed
consent.

- Are willing and able to comply with all study procedures and restrictions.

- Are males or females > 18 years of age and < 50 years of age.

- Are in good health as determined by the investigator based on clinical evaluations
including past medical history, physical examination, vital signs, electrocardiogram,
and laboratory tests at screening and prior to the first dose of study drug.

- Are a current nonsmoker who has not used tobacco- or nicotine-containing products (eg,
nicotine patch) for at least 6 months prior to the first dose of study drug or first
invasive procedure.

- Are a female subject of nonchildbearing potential, documented by medical records or
physician's note to be either surgically sterile (by means of hysterectomy, bilateral
oophorectomy, or tubal ligation) or post-menopausal for at least 1 year (i.e. 12
consecutive months with no menses without an alternative medical cause) or, if they
are of child-bearing potential, must commit to use two methods of contraception, one
of which is a barrier method for the duration of the study.

- Are a male subject who is sterile or agrees to use an appropriate method of
contraception, including a condom with or without spermicidal cream or jelly, from the
first dose of study drug until 30 days after the last dose of study drug. No
restrictions are required for a vasectomized male subject provided the subject is at
least 1-year postbilateral vasectomy procedure prior to the first dose of study drug.
A male subject whose vasectomy procedure was performed less than 1 year prior to the
first dose of study drug must follow the same restrictions as a nonvasectomized man.
Appropriate documentation of surgical procedure should be provided.

- Male subjects must not donate sperm for the study duration and for 30 days following
the last dose of study drug.

Exclusion Criteria:

- Use of any prescription drugs, herbal supplements, within four (4) weeks prior to
initial dosing, and/or over-the-counter (OTC) medication, dietary supplements
(vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an
incidental and limited need), acetaminophen is acceptable, but must be documented as a
concomitant medication / significant non-drug therapy.

- Participation in any clinical investigation within four (4) weeks prior to initial
dosing or longer if required by local regulations, and for any other limitation of
participation based on local regulations.

- Prior participation in other research protocols or clinical care in the last year in
addition to the radiation exposure expected from participation in this clinical study,
such that radiation exposure exceeds the effective dose of 50 millisievert (mSv),
which would be above the acceptable annual limit established by the US Federal
Guidelines.

- Has a known hypersensitivity to any component of the formulation of [18F]MNI-1054 or
related compounds.

- Major surgery, or donation or loss of 400 mL or more of blood within four (4) weeks
prior to initial dosing, or longer if required by local regulation.

- Have a history or presence of any significant cardiovascular, respiratory, hepatic,
renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of
the investigator, are capable of altering the absorption, metabolism, or elimination
of drugs or posing a health risk to participate in the study.

- The subject has a history of cancer (malignancy).

- Have clinically significant findings on laboratory evaluations.

- Have clinically significant findings on ECG evaluation.

- History of immunodeficiency diseases, including a positive HIV test result.

- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.

- History of drug or alcohol abuse within the 12 months prior to screening, or evidence
of such abuse as indicated by the laboratory assays (i.e. positive drug or alcohol
screen) conducted during the screening.

- The subject has a history of alcohol consumption exceeding 2 standard drinks per day
on average (1 glass is approximately equivalent to the following: beer [354 mL/12 oz],
wine [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).

- The subject consumes excessive amounts, defined as greater than 6 servings (1 serving
is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy
drinks, or other caffeinated beverages per day.

- Positive pregnancy test result using serum beta-human chorionic gonadotropin (HCG), if
female.

- Women who are lactating and breastfeeding.

- The subject is an employee of the sponsor or trial site or immediate family member
(e.g., spouse, parent, child, sibling) of the sponsor or trial site.

- MRI exclusion criteria include: Findings of infectious disease, space-occupying
lesions, normal pressure hydrocephalus or any other abnormalities associated with
central nervous system (CNS) disease.

- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps,
cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS
aneurysm clips and other medical implants that have not been certified for MRI, or
history of claustrophobia in MRI.