A Single Center Study to Evaluate the Penetration of RO7033877 Into the Lung in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO7033877 + Bronchoscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO7033877<br> | Drug: RO7033877 + Bronchoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple-dose pharmacokinetics of RO7033877 for plasma, epithelial lining fluid (ELF), and alveolar macrophage (AM): Cmax and AUC |  | 5 days (in-clinic period) | 
| ELF and AM/Plasma Ratios of Cmax and AUC |  | 5 days (in-clinic period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |