A RANDOMIZED, TWO-PERIOD, OPEN-LABEL, SINGLE DOSE CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF AQX-1125 IMMEDIATE RELEASE TABLETS AND CAPSULES IN HEALTHY VOLUNTEERS

AQX 1125 is a new investigational compound that is currently being investigated
for the treatment of inflammatory diseases such as Interstitial
Cystitis/Bladder Pain Syndrome (IC/BPS). AQX 1125 activates the protein called
SHIP1. The SHIP1 protein is involved in diverse processes in your body
including cell growth, cell activation and the regulation of your immune
system.

The purpose of the study is to investigate how quickly and to what extent AQX
1125 in the tablet form and the capsule form are absorbed and eliminated from
the body (this is called pharmacokinetics). The pharmacokinetics of AXQ 1125
after administration as an oral capsule (which has already been investigated)
will be compared to administration of AXQ 1125 as 2 new oral tablets. The
tolerability (any side effects) of AQX-1125 will also be investigated.

The actual study will consist of 2 periods during which you will stay in the
clinical research center in Zuidlaren for 7 days (6 nights). The washout period
between dosing in Period 1 and dosing in Period 2 will be 14 days. This washout
period is to ensure that the study compound is no longer present in your body
at the time you receive the second dose of AQX 1125.

The volunteer will receive AQX 1125 after an overnight fast (at least 10 hours
no eating and drinking) either as an oral capsule (Treatment A) or 2 oral
tablets (Treatment B) with 240 milliliters of tap water.

For both treatments it is applicable that fasting will continue until 4 hours
after administration of the study compound. Then the volunteer will receive a
lunch. During fasting it is allowed to drink water with the exception of 2
hours prior to until 1 hour after administration of the study compound.

The study will consist of 2 periods. In one period the volunteer will receive a
single dose of 200 mg AQX 1125 in the form of an oral capsule (Treatment A), in
the other period the volunteer will receive a single dose of 200 mg AQX 1125 in
the form of 2 oral tablets (100 mg each) (Treatment B).

The order in which the volunteer will receive these treatments (Treatment A-B
or Treatment B-A) will be determined by chance.

Procedures: pain, light bleeding, heamatoma, possibly an infection.

To date, 5 completed clinical studies have been performed with the AQX 1125
oral capsule formulation. Approximately 340 healthy volunteers and patients
have received AQX 1125. Two completed studies tested the 200 mg AQX-1125
capsule in patients with either IC/BPS or chronic obstructive pulmonary
disease. A total of 237 patients received once daily doses of 200 mg AQX 1125
for 6 weeks and 200 patients received once daily doses for 12 weeks. Single and
multiple doses (once daily for up to 10 days) of AQX 1125 up to doses of 542 mg
in volunteers were also well tolerated. The most frequently observed adverse
effects were diarrhea, nausea, dyspepsia (belly discomfort), abdominal (belly)
pain and headache.