Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole

This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the
safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg)
in healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages
18-45 volunteers recruited from one site will participate in this study. The study duration
is approximately 18 months with subject participation of 2 weeks. The primary objective
assess the safety and tolerability of oxfendazole in healthy adults. The secondary
objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of
oxfendazole. Two sentinel subjects will receive the study product (1 drug/1 placebo) in each
group and be monitored 48 hours for adverse events prior to completing enrollment of the
remaining 8 subjects in the group.

Inclusion Criteria:

1. Males and females of non-childbearing potential between the ages of 18 and 45 years,
inclusive.*

*Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who
have been postmenopausal for >/=1 year confirmed by LH and FSH levels.

2. In good health, as judged by the investigator and determined by vital signs*
Temperature < 38 degrees Celsius, heart rate 50 bpm, systolic blood
pressure 89 mmHg, diastolic blood pressure /= 60
mm Hg, medical history and a targeted physical examination. BMI >/=18 and Athletically trained subjects with a pulse >/= 45 may be enrolled at the discretion
of the principal investigator or designated licensed clinical investigator.

3. Acceptable screening laboratories*

*Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts
within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be
equal to or below the upper limit of normal (for eosinophil count, AST, ALT,
creatinine, and total bilirubin values below the normal range are acceptable). Random
blood glucose must be <140. Urine dipstick testing must be negative for glucose and
negative or trace for protein. The following serology tests must be negative: HIV 1/2
antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
HIV and hepatitis C viral load PCR testing may be performed for individuals suspected
of having indeterminate antibody testing.

4. Male participants must be willing to ensure use of condoms and spermicides for 4
months after study drug administration.

5. Provide written informed consent before initiation of any study procedures.

6. Willing to be available for all study-required procedures, and visits for the
duration of the study.

7. Able to provide a home phone number, and the name, address, and/or email of a person
willing to assist with making contact during the follow-up phase of the study.

Exclusion Criteria:

1. History of residing for 6 or more months in regions with endemic cysticercosis as
determined by the principal investigator or a designated study physician.

2. Breastfeeding females.

3. Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute
illness within 3 days before administration of study drug (subject may be
rescheduled).

4. Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver,
kidney, neurologic, gastrointestinal or other system, such that in the opinion of the
investigator participation in the study creates additional risk to the subject, or to
the validity of the study.

5. Use of chronic systemic medications*

*Intermittent use of over the counter medications such as acetaminophen, ibuprofen,
cold and sinus medications are permitted for enrollment (please see section 5.6 for
instructions on medication use during the study).Topical medications, nasal steroids
are permitted throughout the study. Use of the prescription medications used less
than once per week on average are permitted for enrollment (see section 5.6 for
instructions on medication use during the study). If the subject has taken a short
term prescription medication within the past 30 days (e.g. an antibiotic), they
should be postponed from enrollment until 30 days have elapsed since the last dose

6. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole,
mebendazole).

7. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a
psychiatric condition or previous suicide attempt.

8. A history of treatment for any other psychiatric disorder in the past 3 years.*

*Past treatment for ADHD does not exclude participants from enrollment as long as the
medications have been discontinued for a minimum of 3 months and symptoms are well
controlled.

9. Received an experimental agent* within 1 month before administration of study drug or
expect to receive an experimental agent during the 15-day study period.

*Vaccine, drug, biologic, device, blood product, or medication.

10. Any condition that would, in the opinion of the investigator, place them at an
unacceptable risk of injury, render them unable to meet the requirements of the
protocol, or that may interfere with successful completion of the study.

11. A history of alcohol consumption* or any illicit drug use†, or history of substance
abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours prior
to enrollment through day 15.

*Greater than 7 alcoholic drinks per week.

†Other than occasional marijuana use (less than once per week for the past 60 days is
acceptable).

#Alcohol or illicit drugs within the past 3 years.

12. History of chronic tobacco use in the past 60 days.* *A history of occasional tobacco
use (less than 1 pack per week on average) is acceptable. Individuals will be
counseled to abstain from use of tobacco and marijuana from screening through day 15.