Fibrostenotic Crohn’s disease (FCD) Digestive System Inflammatory bowel disease (IBD), Crohn’s disease
Conditions
Interventions
RO7490677: Participants will receive zinpentraxin alfa (RO7490677) as single intravenous (IV) infusion on Day 1 delivered over 70-80 min. Dose escalation in additional cohorts, if required, will be ma
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety measured using the incidence of Adverse Events (AEs) between screening and the end of study treatment, or early discontinuation (approximately up to 64 days) 2. Safety measured using the severity of AEs per National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) grading scale between screening and the end of study treatment, or early discontinuation (approximately up to 64 days) 3. Number of participants with a clinically significant change from baseline in vital signs measured using respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature at screening, check-in (Day -1), and at multiple timepoints until the end of study treatment, or early discontinuation (approximately up to 64 days) 4. Number of participants with a clinically significant change from baseline in clinical laboratory tests assessed using blood and urine samples collected at screening, check-in (Day -1), and at multiple timepoints until the end of study treatment, or early discontinuation (approximately up to 64 days) 5. Number of participants with a clinically significant change from baseline in 12-Lead ECG parameters at screening, check-in (Day -1), and at multiple timepoints until the end of study treatment, or early discontinuation (approximately up to 64 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma concentration of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) 2. Area under the concentration-time curve (AUC) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) 3. Maximum observed concentration (Cmax) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) 4. Total clearance (CL) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) 5. Volume of distribution of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) 6. Terminal drug-elimination half-life (t1/2) of RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) 7. Number of participants with anti-drug antibodies (ADA) to RO7490677 measured using plasma samples collected at predose and at multiple timepoints post-dose until the end of study treatment, or early discontinuation (approximately up to Day 29) | — |
Countries
United States of America
Contacts
Public ContactClinical Trials
Outcome results
None listed