Phase 1 Study of ALZT-OP1 Combination Therapy in Normal Healthy Volunteers

This is an open-labeled, cross-over design, pharmacokinetic study, where 24 subjects will be
randomly assigned to receive treatment regimen A-B or B-A on two consecutive days of dosing.

Two dosing groups are planned for the study :

- Group 1 (n=12)

- Group 2 (n=12)

Each group will be admitted to the Phase I Unit the evening before dosing and will initiate
dosing the next morning for 2-days of consecutive treatment (A-B, or B-A). Both groups will
undergo identical study related procedures, except those subjects that consent to CSF
collection on Day 1 of dosing.

Dose regimen A consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler +
a single oral tablet dose of ALZT-OP1b.

Dose regimen B consists of two oral inhaled doses of ALZT-OP1a, not more than 2 minutes
apart, via dry powder inhaler + two oral tablet doses of ALZT-OP1b.

Plasma Collection, All Subjects (n=24) 1 mL blood samples will be collected at T: 0, 5, 10,
15, 30, 1 hr, 2 hr, 4 hr, and 6 hours, following ALZT-OP1 administration (Days 1 and 2).

CSF Collection, Sub-group (n=12) A sub-group of 12 subjects will be consented for CSF
collection.

1 mL of CSF will be collected at T: 0, 5 min, 30 min, 2 hr, and 4 hours, following ALZT-OP1
administration (Day 1 only).

Inclusion Criteria:

- Provide a signed written informed consent;

- Age 55-75 inclusive;

- ECG within normal limits;

- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2;

- Negative urine drug screen for selected drugs of abuse at screening;

- Negative for hepatitis and HIV at screening;

- Good general health, as determined by medical history, physical examination, and
clinical laboratory testing;

- Willingness to stay in the unit overnight for the duration of the study;

- Consent for CSF collection (for those in CSF group).

Exclusion Criteria:

- Current smokers, or ex-smokers with a remote history (> 100 pack/year);

- Clinically significant medical conditions;

- History of ECG abnormalities;

- Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14
days prior to dosing;

- Signs of active pulmonary infection or other pulmonary inflammatory conditions, even
in absence of febrile episodes, in the last 14 days;

- History or presence of disease in the kidneys and/or heart, lungs, liver,
gastrointestinal tract, endocrine organs or other conditions such as metabolic
disease known to interfere with the absorption, distribution, metabolism, and
excretion of drugs;

- Malignancy, regardless of location;

- Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple
sclerosis, rheumatoid arthritis, or sarcoidosis;

- Investigational agents are prohibited one month prior to entry and for the duration
of the trial;

- Currently taking medications known to be CYP2C9 inducers (i.e. carbamazepine and
rifampicin);

- Currently taking cromolyn, or have taken cromolyn, within the past 30 days;

- NSAID use (products containing ibuprofen while on study);

- Aspirin, or products containing aspirin, while on study;

- Allergy or hypersensitivity to cromolyn (also known as Intal®, Nasalcrom®, etc.);

- Allergy or hypersensitivity to ibuprofen (Advil®, Motrin®, Nuprin®, etc.) or aspirin,
including Stevens-Johnson syndrome;

- History of hypersensitivity or allergies to any of the drug compound under
investigation (cromolyn, ibuprofen, lactose, or magnesium stearate);

- History of clinically significant respiratory disorders and chronic respiratory
disease with impaired respiratory effort or difficulty taking inhaled drugs
(examples: COPD, emphysema);

- Abnormal pulmonary function test, defined for this protocol as: FEV1/FVC < 70% of the
predicted value for the subject, when compared to reference values; AND FEV1 and FVC
< 70% of predicted value when compared to reference values, indicating moderate to
severe respiratory obstruction;

- Any other disease or condition, which, in the opinion of the investigator, would make
the subject unsuitable for this study;

- Female subjects of reproductive potential with a positive pregnancy test (urine or
serum) or who are pregnant or lactating.