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

Phase 1

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Gantenerumab + Placebo	Placebo	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.
Gantenerumab + Placebo	Gantenerumab	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.

Primary Outcome Measures

Name	Time	Method
Local Pain as Assessed Using Visual Analog Scale (VAS)	Immediately after the injection on Day 1

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Anti-Gantenerumab Antibodies (ADAs)	Day 1 (predose [Hour 0]) and Day 85
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
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
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

Locations (1): PRA International Clinical Pharmacology Center (EDS US Clinic)
🇺🇸
Lenexa, Kansas, United States

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