Healthy Volunteer
Conditions
Brief summary
This single-center, open-label study will investigate RO7033877 concentrations in plasma and in various lung compartments, including epithelial lining fluid (ELF), and alveolar macrophages (AM) in healthy volunteers after multiple intravenous (IV) administration. Bronchoscopy will be performed after the start of the last infusion on Day 3 at different timepoints. Blood, urine and brochoalveolar lavage samples will be collected to determine RO7033877 concentrations. The anticipated time on study treatment is 3 days.
Interventions
DRUGRO7033877 + Bronchoscopy
Days 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female healthy volunteers, 18 to 55 years of age, inclusive. A female participant is eligible to participate if she is of non-childbearing potential defined as postmenopausal or surgically sterile * Healthy 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 and urinalysis * Body mass index (BMI) between 18 and 30 kg/m2 inclusive * Nonsmokers * Healthy male volunteers with female partners of childbearing potential must use adequate contraception methods
Exclusion criteria
* Evidence of active chronic disease * Regular consumption of drugs of abuse * Infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) * History of clinically significant hypersensitivity or allergic drug reactions * Clinically significant abnormalities (e.g. cardiovascular, laboratory values) * Abnormal blood pressure or vital signs * Contraindications to bronchoalveolar lavage (BAL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ELF and AM/Plasma Ratios of Cmax and AUC | 5 days (in-clinic period) |
| Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC | 5 days (in-clinic period) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to 12 days |
| Changes in clinical laboratory safety tests, vital signs, and ECGs | Up to 6 weeks |
Countries
United States
Outcome results
None listed