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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Drug: Gantenerumab

• Registration Number: NCT02711423
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-17
• Study Start: 2016-03-31
• Primary Completion: 2016-09-28
• Study Completion: 2016-09-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-08
• Last Update Posted: 2019-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part I (Dose Escalation): Placebo	Placebo	Participants will receive a single SC dose of matching placebo on Day 1.
Part II (PK Extension): Gantenerumab	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.
Part I (Dose Escalation): Gantenerumab	Gantenerumab	Participants will receive a single SC dose of gantenerumab on Day 1.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Bioclinica Research; 🇺🇸 Orlando, Florida, United States