A study to evaluate the safety, tolerability, and processing by the body of single-ascending doses of RO7490677 in healthy participants
- Conditions
- Fibrostenotic Crohn’s disease (FCD)Digestive SystemInflammatory bowel disease (IBD), Crohn’s disease
- Registration Number
- ISRCTN12950872
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 24
1. Aged =18 and =65 years at the time of signing the Informed Consent Form (ICF)
2. Body mass index (BMI) =18 and =32 kg/m² at screening
3. Weight =45 and =100 kg at screening
4. Clinical laboratory evaluations (not including lymphocyte subsets) at screening and on Day -1 within the reference range for the test laboratory unless deemed not clinically significant by the investigator
5. Ability to restrict alcohol intake (=2 servings of alcohol per day, where: one serving is 12 ounces of beer, 5 ounces of wine, 1.5 ounces of spirits, or equivalent), to refrain from the use of tobacco or nicotine products (smoking/vaping), and to refrain from illicit drug use during the study
6. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
7. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm
1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 8 weeks after the final dose of the study drug
2. Major surgery within 8 weeks prior to screening, or planned major surgery during the study or planned within 3 months after the dose of study drug
3. History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, haematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders, as determined by the investigator
4. History of serious or uncontrolled hypertension or treatment with antihypertensive medications
5. History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
6. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
7. Treatment with any immunosuppressive medication within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
8. Donation of blood or plasma from 30 days prior to screening through study completion or end of treatment (ET), inclusive
9. Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
10. Use of biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
11. Use of tobacco or nicotine products including electronic cigarettes (i.e. vaping) within 3 months of screening, as indicated by medical history or urine cotinine levels
12. Positive for hepatitis C virus (HCV) antibody and RNA, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at screening
13. Positive for coronavirus (COVID-19) infection at screening and Day -1
14. Positive for tuberculosis (TB) during screening or within 3 months prior to screening
15. History of or currently active primary or secondary immunodeficiency
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method