A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers

Study Overview
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Brief Summary
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This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.

Official Title
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A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Gantenerumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males 18 to 45 years of age, inclusive Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m^2), inclusive Exclusion Criteria: History of cancer or any clinically significant disease affecting one of the major organ systems Prior administration of gantenerumab Clinically significant laboratory test results Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent Known hypersensitivity to gantenerumab or excipients of study drug formulation Abnormal skin condition or potentially obscuring tattoo, pigmentation, or lesion in the area intended for SC injection Familial history of early-onset Alzheimer's disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part I (Dose Escalation): Gantenerumab<br>Participants will receive a single SC dose of gantenerumab on Day 1. | Drug: Gantenerumab<br>* Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.<br>|
| Placebo Comparator: Part I (Dose Escalation): Placebo<br>Participants will receive a single SC dose of matching placebo on Day 1. | Drug: Placebo<br>* Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.<br>|
| Experimental: Part II (PK Extension): Gantenerumab<br>Participants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I. | Drug: Gantenerumab<br>* Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with adverse events (AEs) |  | Up to 12 weeks (from Baseline to Day 85 +/- 5 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) of gantenerumab |  | Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85 | 
| Area under the plasma concentration-time curve (AUC) of gantenerumab |  | Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85 |