A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
No history of malignancy
Documentation of age-appropriate cancer screening based on local/country-specific guidelines
For women of childbearing potential: agreement to remain abstinent or use contraceptive methods
For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
For HVs Only:
Age 18 - 50
Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m2), inclusive
In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs, and clinical laboratory evaluations should be within the reference range for the test laboratory unless deemed not clinically significant by the investigator and Sponsor
For Participants with UC or CD:
Age 18 - 80
Eligible to receive biologic therapy
Disease duration of \>/= 12 weeks
Diagnosis of moderate to severe UC or CD
You may not be if
History of inflammatory skin disorders
History of any cancer
History of anaphylaxis, hypersensitivity, or drug allergies
History of alcoholism or drug addiction
Positive tests indicating infection for hepatitis C, hepatitis B, or HIV
Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days or 5 half-lives of investigational product, whichever is greater, prior to study drug administration
Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 90 days or 5 half-lives, whichever is greater, prior to study drug administration
History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
Family history of sudden unexplained death or long QT syndrome
Any acute or chronic condition that would limit the subject's ability to complete and/or participate in this clinical study
Pregnant or lactating, or intending to become pregnant for duration of study
For HVs Only:
Known family history of gastrointestinal (GI) and/or colon cancer
Prior exposure to UTTR1147A
For Participants with UC or CD:
Significant uncontrolled co-morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders
History of primary sclerosing cholangitis
Active anti-TNF induced psoriasiform or eczematous lesions
Moderate to severe anemia
Presence of an ileostomy or colostomy
Total proctocolectomy
Positive screening for latent mycobacterial tuberculosis infection
Impaired renal function
Impared hepatic function
Clareo Health | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
