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

NCT02711423 | Completed Phase 1 FDA Drug

• 2 other identifiers: BP300422015-005132-17
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adverse events (AEs)

  Up to 12 weeks (from Baseline to Day 85 +/- 5 days)

Secondary Outcomes (2)

• 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

Study Arms (3)

Part I (Dose Escalation): Gantenerumab

EXPERIMENTAL

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

Drug: Gantenerumab

Part I (Dose Escalation): Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Part II (PK Extension): Gantenerumab

EXPERIMENTAL

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.

Drug: Gantenerumab

Interventions

Gantenerumab 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): Gantenerumab; Part II (PK Extension): Gantenerumab

Placebo 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 I (Dose Escalation): Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Bioclinica Research

Orlando, Florida, 32806, United States

Location

MeSH Terms

Interventions

gantenerumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 17, 2016
• Study Start: March 31, 2016
• Primary Completion: September 28, 2016
• Study Completion: September 28, 2016
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)