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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Gantenerumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02882009

WP39322

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Gantenerumab + Placebo

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Gantenerumab