Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants

• ClinicalTrials.gov Identifier: NCT03236844
• Recruitment Status: Completed
• First Posted: August 2, 2017
• Last Update Posted: December 12, 2018
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Tracking Information

• First Submitted Date: July 31, 2017
• First Posted Date: August 2, 2017
• Last Update Posted Date: December 12, 2018
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2017)

• Maximum Observed Plasma Concentration (Cmax) of Gantenerumab [ Time Frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85 ]
• Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf) [ Time Frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 31, 2017)

• Local Pain Assessments Using Visual Analog Scale (VAS) [ Time Frame: After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3 ]
• Local Pain Assessments Using Verbal Rating Scale (VRS) [ Time Frame: After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3 ]
• Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions [ Time Frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3 ]
• Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions [ Time Frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3 ]
• Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months) ]
• Percentage of Participants With Anti-Gantenerumab Antibodies [ Time Frame: Predose (any time before injection) on Day 1 and on Day 85 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants
• Official Title: A Multi-Center, Randomized, Open-Label, Single-Dose, Parallel Group Study to Investigate the Relative Bioavailability of Gantenerumab Produced With the G4 Process in Comparison to Gantenerumab Produced With the G3 Process Following Administration by Subcutaneous Injection in Healthy Volunteers
• Brief Summary: The purpose of this study is to assess the relative bioavailability of the high concentration liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the same HCLF of gantenerumab produced with the G3 process in healthy participants following single SC dose administration.
• Detailed Description: This multi-center, randomized, open-label, single dose, parallel-group study will assess the relative bioavailability and the safety and tolerability of gantenerumab produced with the G4 process in comparison to gantenerumab produced with the G3 process. All participants will receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day 1. The total duration of the study for each participant will be up to 21 weeks: Screening (up to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and Safety Follow-up (up to 90 days after dosing).
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Healthy Participants

Intervention

Drug: Gantenerumab

Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).

Other Name: RO4909832

Study Arms

• Experimental: Gantenerumab G4
  Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.
  Intervention: Drug: Gantenerumab
• Experimental: Gantenerumab G3
  Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.
  Intervention: Drug: Gantenerumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 31, 2017): 114
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 15, 2017
• Actual Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy participant
• Body mass index (BMI) between 18.0 and 30.0 kilograms per meter-square (kg/m^2), inclusive
• Body weight between 55 to 110 kg inclusive
• Female participants with either non-childbearing potential or with childbearing potential who commit to remain abstinent or use acceptable contraceptive methods during the treatment period and until at least 6 months after the follow-up visit
• Women of childbearing potential must have a negative serum pregnancy test result at screening and Day 1

Exclusion Criteria:

• History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
• History or suspicion of drugs of abuse addiction
• History or suspicion of alcohol addiction
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 17 weeks after the last dose of study drug
• Prior administration of gantenerumab
• Clinically significant abnormalities (as judged by the investigator) in laboratory test results (including complete blood count, chemistry panel, and urinalysis)
• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03236844
• Other Study ID Numbers: WP40052
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Same as current
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: December 2018