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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236844
• Other study ID #: WP40052
• Status: Completed
• Phase: Phase 1
• Start date: August 1, 2017
• Est. completion date: December 15, 2017

Study information

• Verified date: December 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 15, 2017
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	Percentage of Participants With Anti-Gantenerumab Antibodies		Predose (any time before injection) on Day 1 and on Day 85