PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, 66219, United States
NCT Number: NCT02882009
The purpose of this randomized, open-label, parallel-group, placebo-controlled study is to assess pain following subcutaneous (SC) administration of gantenerumab as a high-concentration liquid formulation (HCLF) at different injection speeds. The total duration of the study for each healthy participant will be up to approximately 21 weeks.
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Notify Me40 year–80 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.
Other names: RO4909832
Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.
Time frame: Immediately after the injection on Day 1
Time frame: 0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85
Time frame: 0 to 20 minutes after injection on Day 1
Time frame: Immediately after the injection on Day 1
Time frame: Immediately post-dose to 6 hours on Day 1
Time frame: From Screening to Day 85
Time frame: Day 1 (predose [Hour 0]) and Day 85
Time frame: 0 hour (predose) and 6, 12, and 24 hours postdose on Day 1, on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 43, 64, 85
Hoffmann-La Roche
Industry
A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers
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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