Tolerability, Pharmacokinetics, and Efficacy of APD371 in Subjects With Crohn's Disease Experiencing Abdominal Pain

Key Inclusion Criteria:

- A clinical diagnosis of Crohn's disease for at least 3 months prior to screening
corroborated by prior endoscopic and histopathologic documentation consistent with
Crohn's disease.

- Quiescent to mildly active inflammatory Crohn's disease defined with a total of SES-CD
score of < 10 or FCP < 500 mcg/g within 4 weeks before Screening.

- Moderate to severe abdominal pain as defined by AAPS of >/= 4points on 7 consecutive
days of the screening period up to Day -2. AAPS will be based on the 11-point numeric
rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

Key Exclusion Criteria:

- Female subjects who are lactating or have a positive serum pregnancy test during the
screening period or a positive urine pregnancy test on Day 1 prior to study drug
administration.

- Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute
Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial
infarction, unstable angina.

- Other significant chronic pain conditions that in the opinion of the Investigator may
influence the abdominal pain score.

- History of extensive colonic resection, subtotal or total colectomy.

- History of >3 small bowel resections or diagnosis of short bowel syndrome or who have
undergone bowel resection within 6 months prior to randomization.

- Chronic active hepatitis B within the last year (unless shown at the time of study
entry to be hepatitis B antigen negative) or any history of hepatitis C.

- Evidence of current gastro-intestinal infection (bacterial or parasitic) or
significant infection within 45 days of screening.

Note: other protocol defined Inclusion/Exclusion criteria may apply.