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

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lycera Corp.

Criteria

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