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

Lycera

Status and phase

Completed

Phase 1

Conditions

Ulcerative Colitis

Treatments

Drug: LYC-30937

Study type

Interventional

Funder types

Industry

Identifiers

NCT02818543

LYC-30937-1002

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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