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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-09-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part I (Dose Escalation): Gantenerumab

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

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.

Part I (Dose Escalation): Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.

Part II (PK Extension): Gantenerumab

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.

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.

Interventions

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Gantenerumab

Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.

Intervention Type DRUG

Placebo

Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes