Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis

An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis

The purpose of this study to assess the pharmacokinetic profile in patients with active ulcerative colitis and compare it to the experience in healthy volunteers.

Inclusion Criteria:

• Active ulcerative colitis defined as a Mayo endoscopy score of ≥ 2 despite therapy.
• Male or female age 18 to 75
• May be receiving a therapeutic dose of an oral 5-amino salicylic acid compound or oral corticosteroid therapy

Exclusion Criteria:

• Current anti-tumor necrosis factor use
• Current immunosuppressant use (Note: this does not include corticosteroid use)
• Subjects with only distal active disease (i.e. proctitis)
• Clinically significant active infection
• Known bleeding disorder, a risk of bleeding or hypercoagulable disorders in which an anticoagulant is required
• History of malignancy within the last 5 years except non-melanoma skin cancer or cervical carcinoma in situ
• Clinically significant lab abnormalities (i.e. liver function abnormalities, renal insufficiency, abnormal absolute neutrophil count or hemoglobin)
• History of colon resection
• Any other investigational therapy or investigational biologics use within 8 weeks of investigational medicinal product administration