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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: Gantenerumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02711423

BP30042

2015-005132-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups, including a placebo group

Part I (Dose Escalation): Gantenerumab

Experimental group

Description:

Participants will receive a single SC dose of gantenerumab on Day 1.

Treatment:

Drug: Gantenerumab

Part I (Dose Escalation): Placebo

Placebo Comparator group

Description:

Participants will receive a single SC dose of matching placebo on Day 1.

Treatment:

Drug: Placebo

Part II (PK Extension): Gantenerumab

Experimental group

Description:

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.

Treatment:

Drug: Gantenerumab