A Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CCX507-H in Healthy Male and Female Subjects

CCX507-H is a new investigational compound that may eventually be used for the
treatment of inflammatory bowel diseases, such as Chron*s disease. CCX507-H is
not registered as a drug. This is the first time that this compound is being
given to humans.

Primary:
to evaluate the safety and tolerability of single oral doses of CCX507-H, over
a range of 3 dose levels, in healthy male and female subjects

Secondary:
to evaluate the following:
* Single dose pharmacokinetic profile (PK) of CCX507-H over a range of 3 dose
levels;
* The relative PK profile of CCX507-H given as different formulations;
* The effect of food on the PK profile of CCX507-H; and
* The relationship between CCX507 plasma concentrations and inhibition of C-C
chemokine receptor 9 (CCR9)-mediated cell migration

Screening and follow-up:
clinical laboratory, full physical examination, ECG, vital signs; at
eligibility screening: medical history, drug screen, HBsAg, anti HCV, anti-HIV
1/2 and pregnancy test (females only)

Observation period:
in clinic from -18h (Day -1) up to 24h (Day 2) after drug administration (Day
1) with ambulatory visits on Day 3 and 4
cohort 3b and 3c will return for a second (similar) period (food-effect) with a
wash-out of 7 days between the two dosing days

Blood sampling:
For pharmacokinetics:
Prior to administration of study medication (Time 0), and at Hours 0.08 (5
minutes post dose), 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 20, 24, 48, and
72 after administration of study medication.
For pharmacodynamics:
At baseline (within 2 hours prior to dosing), and at Hours 2, 12, and 24 after
administration of study medication

Urine sampling:
For pharmacokinetics: Day 1 at interval 0-6h

Safety assessments:
Adverse events throughout the study; clinical laboratory, hematology,
urinalysis, physical examination, vital signs, 12-lead-ECG and weight at
screening and follow-up

Cohort 1: 3 mg CCX507-H or placebo as dosing solution in the fasted state
Cohort 2: 10 mg CCX507-H or placebo as dosing solution in the fasted state
Cohort 3a: 30 mg CCX507-H or placebo as dosing solution in the fasted state
Cohort 3b:
Period 1: 30 mg CCX507-H or placebo in gelatin capsules in the fasted state
Period 2: 30 mg CCX507-H or placebo in gelatin capsules in the fed state
Cohort 3c:
Period 1: 30 mg CCX507-H or placebo as a semi-solid formulation in gelatin
capsules in the fasted state
Period 2: 30 mg CCX507-H or placebo as a semi-solid formulation in gelatin
capsules in the fed state

* Registration of adverse effects: During the entire investigation all adverse
effect you report will be documented.
* Blood draw, indwelling canula: During this study not more than 600 ml of
blood will be drawn. An indwelling cannula will be used once (per period, so in
total twice for Group 3b and 3c). The remainder of the blood draws will be
drawn by direct puncture of the vein.
* Collection of urine: Urine will be collected starting after dosing until 6
hours after administration of CCX507-H
* Heart trace (ECG*s): ECG*s will be made regularly: specifically on the day(s)
of study drug administration