Safety Study of Ch-mAb7F9 for Methamphetamine Abuse

There will be 5 dose groups. At the beginning of dosing in each group, 1 subject will
receive the normal saline placebo and 1 will receive the active dose. The remainder of the
dose group will receive their doses beginning 48 hr later, after safety evaluations. Dosing
of the remaining subjects in each dose group will occur 1 at a time, with dosing in each
subsequent subject separated by a minimum of 24 hr. Subsequent dose groups will receive
their doses beginning approximately 2 weeks after dosing in the preceding group, pending
safety analyses.

The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg,
respectively. The starting dose will be 0.2 mg/kg, and the highest dose will be 20 mg/kg (up
to a maximum of 1,500 mg), which is at least 20-fold lower than the no observable adverse
effect level (NOAEL) in rats to ensure subject safety.

Ch-mAb7F9 will be administered intravenously (IV) with a saline flush to clear the
administration tubing of residual ch-mAb7F9. Each dose of ch-mAb7F9 will be diluted in 225
ml of saline and given over two hours.

Inclusion Criteria:

Subjects with the following criteria may be considered for inclusion in the study:

1. Subject voluntarily agrees to participate in this study and signs an IRB-approved
informed consent form prior to performing any of the screening procedures.

2. Healthy, determined by the PI based on pre-study medical evaluation (medical history
and physical examination, vital signs, ECG, and clinical laboratory evaluations).

3. Males or females between 18 to 50 years of age, inclusive.

4. The following applies to female subjects:

- Nonchildbearing potential (surgically sterile [hysterectomy, bilateral
oophorectomy, or bilateral tubal ligation/occlusion] or post-menopausal 1 year with
follicle stimulating hormone [FSH] > 40 U/L).

OR

- Nonpregnant, nonlactating females of childbearing age who agree to use medically
acceptable forms of birth control (oral contraceptive pills; contraceptive patches;
vaginal ring; diaphragm, sponge, or condom with spermicide; hormone injection; or
intrauterine device) from screening to end of study follow-up, or whose partner has
had a vasectomy.

5. The following applies to male subjects:

- Need to have had a vasectomy or agree to use a condom and spermicide in addition
to their female partners using a form of birth control.

- Agree not to donate sperm for 90 days post dose.

6. Body mass index (BMI) between 18.5 and 30.5 kg/m2, inclusive, at screening. Body
weight ≥ 50 kg and ≤ 100 kg at screening.

7. Nonsmokers or light smokers (< 10 cigarettes per day) able to refrain from smoking
during the in-house period.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. A history of treatment with a monoclonal antibody in the past year,

2. likely allergy or sensitivity to ch-mAb7F9 based on known allergies to other mAbs, or
which, in the opinion of the Principal Investigator (PI), suggests an increased
potential for an adverse hypersensitivity to ch-mAb7F9,

3. a history of severe allergy (rash, hives, breathing difficulty, etc.) to any
medications, either prescription or nonprescription, including dietary supplements or
herbal medications,

4. a history of allergic or environmental bronchial asthma,

5. a clinically significant history of or current abnormality or disease of any organ
system, including renal, hepatic, gastrointestinal, cardiovascular, pulmonary
(including chronic asthma), endocrine (eg, diabetes), central nervous, or hematologic
systems, or recent clinically significant surgery,

6. a history of seizure, epilepsy, severe head injury in the opinion of the PI, multiple
sclerosis, or other known neurological conditions,

7. abnormal pre-admission vital signs, physical examination, clinical laboratory, or any
safety variable which is considered clinically significant for this population by the
PI or Sponsor (or designee), (volunteers who have or are suspected to have Gilbert's
syndrome will be discussed on a case by case basis by the PI, Medical Monitor, and
Sponsor),

8. a planned or scheduled surgical procedure during the study,

9. a clinically significant mental or physical illness within 1 year prior to the first
dose, including a history of alcohol and/or drug abuse (DSM IV criteria) within 1
year prior to the first dose of study medication,

10. any history of stimulant use or abuse, including methamphetamine, amphetamine, or
MDMA (ecstasy),

11. a recent (within 30 days of the first dose of study medication) donation of plasma or
blood,

12. treatment with any medications, either prescription or nonprescription, including
dietary supplements or herbal medications, within 14 days prior to the first dose of
study medication (exceptions are nonprescription topical medications that are not
systemically absorbed, acetaminophen, or vitamins at recommended daily doses),

13. ingestion of any known hepatic or renal clearance altering agents (e.g.,
erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.) within
a period of 90 days prior to the first dose of study medication,

14. ingestion of any approved prescription anti-obesity drug or taken any
over-the-counter medication for weight loss within a period of 90 days prior to the
first dose of study medication,

15. ingestion or use of any investigational medication or device within 30 days prior to
the first dose of study medication; ingestion or use of any investigational
anti-obesity medication is prohibited within 3 months prior to the first dose of
study medication,

16. acute illness within 5 days prior to the first dose of study medication, e.g., flu
syndrome, gastrointestinal (GI) virus, or clinically significant indigestion (e.g.,
reflux) based on the discretion of the PI,

17. a positive test for HBsAG, Hepatitis C antibody, Hepatitis A IgM, or Human
Immunodeficiency Virus (HIV) Viral Serology tests at the screening visit,

18. a positive urine alcohol test at screening or on Day -1; positive urine drug test for
illicit substances (amphetamines, barbiturates, benzodiazepines, cocaine, opiates,
tetrahydrocannabinol [THC], phencyclidine, propoxyphene or MDMA) at screening or Day
-1.

19. limited mental capacity to the extent that the subject cannot provide legal consent
or understand information regarding the study,

20. a requirement for a special diet other than vegetarian or has a significant food
allergy or intolerance,

21. any subject judged by the PI or Sponsor (or designee) to be inappropriate for the
study.