A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.

Official Title
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A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers

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 male and female participants (healthy status is defined by the 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, hematology, blood chemistry, coagulation, serology, and urinalysis) Body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m^2), inclusive Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit Exclusion Criteria: History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis History or suspicion of drugs of abuse or alcohol addiction Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history Pregnant or lactating women Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2 Any familial history of early onset Alzheimer's disease Prior administration of gantenerumab Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gantenerumab + Placebo<br>Participants will be randomized to receive gantenerumab HCLF and placebo solution via SC injection according to different sequences for the site of administration and different injection speeds. | Drug: Gantenerumab<br>* Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.<br>* Other names: RO4909832;Drug: Placebo<br>* Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Pain as Assessed Using Visual Analog Scale (VAS) |  | Immediately after the injection on Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Gantenerumab |  | 0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85 | 
| Area Under the VAS Pain-Time Curve From Time 0 to 20 Minutes (AUC[0-20]) |  | 0 to 20 minutes after injection on Day 1 | 
| Local Pain as Assessed Using Verbal Rating Scale (VRS) Score |  | Immediately after the injection on Day 1 | 
| Number of Participants With Skin Reactivity, as Assessed Using a 0 (No Reactivity) to 3 (Severe Reactivity) Scale |  | Immediately post-dose to 6 hours on Day 1 | 
| Number of Participants With Adverse Events |  | From Screening to Day 85 | 
| Number of Participants With Anti-Gantenerumab Antibodies (ADAs) |  | Day 1 (predose [Hour 0]) and Day 85 | 
| Maximum Observed Plasma Concentration (Cmax) of Gantenerumab |  | 0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85 |