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NCT Number: NCT02711423

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bioclinica Research

Orlando, Florida, 32806, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of participants with adverse events (AEs)

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

Secondary outcomes

  1. Maximum observed plasma concentration (Cmax) of gantenerumab

    Time frame: 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

  2. Area under the plasma concentration-time curve (AUC) of gantenerumab

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2016
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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