Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGGantenerumab
Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.
DRUGPlacebo
Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local Pain as Assessed Using Visual Analog Scale (VAS) | Immediately after the injection on Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Number of Participants With Adverse Events | From Screening to Day 85 |
Countries
United States
Outcome results
None listed