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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Gantenerumab

• Registration Number: NCT03236844
• Lead Sponsor: Hoffmann-La Roche

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...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study Start: 2017-08-01
• Study First Posted: 2017-08-02
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gantenerumab G4	Gantenerumab	Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.
Gantenerumab G3	Gantenerumab	Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Gantenerumab	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)	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

Secondary Outcome Measures

Name	Time	Method
Local Pain Assessments Using Visual Analog Scale (VAS)	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)	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
Percentage of Participants With Anti-Gantenerumab Antibodies	Predose (any time before injection) on Day 1 and on Day 85
Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions	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	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)	AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)

Trial Locations

Locations (3)

PRA International Clinical Pharmacology Center (EDS US Clinic); 🇺🇸 Lenexa, Kansas, United States

PRA; 🇺🇸 Marlton, New Jersey, United States

PRA Health Sciences; 🇺🇸 Salt Lake City, Utah, United States