Healthy participants Not Applicable
Conditions
Interventions
Participants will be enrolled in multiple cohorts to receive zosurabalpin from Day 1 to Day 10, at the assigned doses, as an IV infusion through a PICC line. Subsequent doses will be selected in an ad
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Able and willing to provide written informed consent and to comply with the study protocol. 2. Participants must weigh at least 50 kilogram (kg) and must have a body mass index (BMI) within the range of 18 to 32 kg per square meter (kg/m2) (inclusive) at screening. 3. Health status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, coagulation, and urinalysis. 4. Participants must agree to remain abstinent or at least one highly effective contraceptive method.
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis. 2. Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study. 3. History of malignancy. 4. Use of glucocorticoids and other immunosuppressive medications within 30 days (or within 5 times the elimination half-life, whichever is longer) prior to Day 1 and until follow-up. 5. Are currently enrolled in, have participated in, or plan to participate in this or any other clinical study involving an investigational medicinal product (IMP) or medical device study from within the 30 days directly preceding screening or within 5 times the elimination half-life, if known (whichever is longer), until the completion of the follow-up visit. 6. Participation in four or more interventional clinical studies within 12 months prior to enrollment (Day 1). 7. Donation of blood or blood products for transfusion over 100 mL in the last 30 days or 500 mL in the last 3 months or had significant blood loss within 3 months prior to the first study treatment administration. 8. Participants with insufficient venous access. 9. History of hypersensitivity to any of the excipients in the formulation of zosurabalpin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events (AEs), as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) From Screening up to Day 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma Pharmacokinetic (PK) Parameters of Zosurabalpin Measured Using a Validated Liquid Chromatography Mass Spectrometry (LC-MS/MS) Assay From Day 1 up to Day 16 2. Urine PK Parameters of Zosurabalpin Measured Using a Validated LC-MS/MS Assay From Samples Collected on Multiple Time-points From Day 1 to Day 11 | — |
Countries
Netherlands
Contacts
Public ContactClinical Trials
Outcome results
None listed