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

A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02711423

Enrollment

Registered

2016-03-17

Start date

2016-03-31

Completion date

2016-09-28

Last updated

2019-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGGantenerumab

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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of participants with adverse events (AEs)	Up to 12 weeks (from Baseline to Day 85 +/- 5 days)

Secondary

Measure	Time frame
Maximum observed plasma concentration (Cmax) of gantenerumab	Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Area under the plasma concentration-time curve (AUC) of gantenerumab	Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026