Blood sampling techniques Not Applicable
Conditions
Interventions
Crenezumab
Subjects in the crenezumab treatment group will receive a single intravenous dose of 15 mg/kg crenezumab.
Etrolizumab
Subjects in the etroli
Sponsors
Roche (United States)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Body mass index 18-32 kg/m2 2. Body weight 45-120 kg 3. Good health, as demonstrated by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs 4. Clinical laboratory evaluations (including chemistry panel [fasted at least 8 hours], CBC, coagulation testing [PT, INR, aPTT, and fibrinogen], and urinalysis [see Appendix 5]) within the reference range for the respective test laboratory, unless deemed not clinically significant by the investigator 5. Negative test for selected drugs of abuse at screening (does not include alcohol) and at check-in (Day -1) (does include alcohol) 6. Negative hepatitis panel (including hepatitis B surface antigen, hepatitis B virus core antibody, and hepatitis C virus antibody) and negative human immunodeficiency virus (HIV) antibody screens 7. Negative screening test for latent mycobacterium tuberculosis (TB) infection by QuantiFERON® TB Gold Indeterminate results may be confirmed by repeat test or by a purified protein derivative (PPD) skin test 8. Agreement to refrain from strenuous exercise from 48 hours prior to check-in (Day -1) and during the study duration 9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs 10. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding, or intention to become pregnant during the study or within the following time windows after the dose of study treatment: 1.1. 8 weeks after the dose of crenezumab 1.2. 24 weeks after the dose of etrolizumab 1.3. 9 days after the dose of giredestrant 1.4. 29 weeks after the dose of hydroxychloroquine 2. Significant history or clinical manifestation of any metabolic, immunologic, allergic, dermatological, hepatic, renal, hematological, pulmonary, respiratory, cardiovascular, gastrointestinal, neurological, or psychiatric disorder, acute infection, or other unstable medical disease (as determined by the Investigator) 3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator 4. History or presence of an abnormal ECG that, in the Investigator’s opinion, is clinically significant 5. QTcF interval of > 450 ms for males or > 470 ms for females; PR interval of > 210 ms; or QRS complex of >120 ms 6. History of alcoholism or drug addiction within 6 months prior to check-in (Day -1) that, in the judgment of the Investigator, may put the subject at risk for being unable to participate for the full duration of the study 7. History of malignancy, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or completely excised basal cell or squamous cell carcinoma of the skin 8. History of active or latent TB, regardless of treatment history 9. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives or 30 days (whichever is longer) prior to check-in (Day -1) 10. Receipt of any prescription medications/products within 14 days prior to check-in (Day -1), unless deemed acceptable by the investigator 11. Receipt of any new over-the-counter (OTC), non-prescription preparations (including vitamins; minerals; and phytotherapeutic-, herbal-, and plant-derived preparations) within 7 days prior to check-in (Day -1), unless deemed acceptable by the Investigator 12. Consumption of alcohol-containing foods or beverages within 72 hours prior to check-in (Day -1), unless deemed acceptable by the Investigator 13. Use of tobacco- or nicotine-containing products (including, but not limited to, cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months prior to check-in (Day -1) 14. Donation of blood within 30 days prior to screening or plasma within 2 weeks prior to screening 15. Receipt of blood products within 2 months prior to check-in (Day -1) 16. Poor peripheral venous access 17. Any acute or chronic condition that, in the investigator’s judgment, would limit the subject’s ability to complete and/or participate in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Drug concentrations collected using venipuncture versus low-volume sampling performed by trained site staff and evaluated using the bioanalytical method comparability criteria on Days 1, 2, 4, 8, 15, 29, 43, 57, 85 for crenezumab and etrolizumab; Days 1, 2, 3, 5, 6, 7 and 8 for giredestrant and Days 1, 2, 3, 4, 6, 8, 15, 29, 43, 57 and 85 for hydroxychloroquine 2. Evaluation of bias and impact to interchangeability (i.e., no trend over the range of concentrations) using 90% confidence intervals at Days 1, 2, 4, 8, 15, 29, 43, 57, 85 for crenezumab and etrolizumab; Days 1, 2, 3, 5, 6, 7 and 8 for giredestrant and Days 1, 2, 3, 4, 6, 8, 15, 29, 43, 57 and 85 for hydroxychloroquine 3. Determination of equivalent operational performance for venipuncture and low-volume sampling techniques on the basis of the number of failed samples and the number of outliers assessed at Days 1, 2, 4, 8, 15, 29, 43, 57, 85 for crenezumab and etrolizumab; Days 1, 2, 3, 5, 6, 7 and 8 for Giredestrant and Days 1, 2, 3, 4, 6, 8, 15, 29, 43, 57 and 85 for hydroxychloroquine 4. PK parameters from samples obtained using venipuncture, Neoteryx Mitra (whole blood), and TASSO-Plus (serum for monoclonal therapeutics or plasma for small molecules) collected by trained site staff at Days 1, 2, 4, 8, 15, 29, 43, 57, 85 for crenezumab and etrolizumab; Days 1, 2, 3, 5, 6, 7 and 8 for giredestrant and Days 1, 2, 3, 4, 6, 8, 15, 29, 43, 57 and 85 for hydroxychloroquine | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety evaluated on the basis of the incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0, change from baseline in targeted vital signs, and change from baseline in targeted clinical laboratory test results at Check-In, Days 1, 2, 4, 8, 15, 29, 43, 57, 85 for crenezumab and etrolizumab; Check-In, Days 1, 2, 3, 5, 6, 7 and 8 for giredestrant and Check-In, Days 1, 2, 3, 4, 6, 8, 15, 29, 43, 57 and 85 for hydroxychloroquine 2. Incurred sample reanalysis feasibility on samples collected from Mitra tips assessed using evaluation of frozen whole blood extracts to freeze thaw at Days 1, 2, 4, 8, 15, 29, 43, 57, 85 for crenezumab and etrolizumab; Days 1, 2, 3, 5, 6, 7 and 8 for giredestrant and Days 1, 2, 3, 4, 6, 8, 15, 29, 43, 57 and 85 for hydroxychloroquine 3. Subject experience with low-volume sampling techniques compared with venepuncture assessed using patient satisfaction survey at Days 15, 85 for crenezumab and etrolizumab; day 8 for giredestrant and Days 2, 15 and 85 for hydroxychloroquine | — |
Countries
United States of America
Contacts
Public ContactTrial Information Support Line (TISL)
Outcome results
None listed