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Completed

NCT Number: NCT03236844

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

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.

Completed

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Key information

Conditions

Healthy Participants

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

gantenerumab

Drug

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

Other names: RO4909832

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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)

  6. Percentage of Participants With Anti-Gantenerumab Antibodies

    Time frame: Predose (any time before injection) on Day 1 and on Day 85

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 2, 2017
Registry last updated
Dec 12, 2018

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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