NCT02882009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

August 31, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2017

Completed
Last Updated

June 11, 2019

Status Verified

June 1, 2019

Enrollment Period

7 months

First QC Date

August 24, 2016

Last Update Submit

June 7, 2019

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Local Pain as Assessed Using Visual Analog Scale (VAS)

    Immediately after the injection on Day 1

Secondary Outcomes (7)

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUC[0-inf]) of Gantenerumab

    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

  • Area Under the VAS Pain-Time Curve From Time 0 to 20 Minutes (AUC[0-20])

    0 to 20 minutes after injection on Day 1

  • Local Pain as Assessed Using Verbal Rating Scale (VRS) Score

    Immediately after the injection on Day 1

  • Number of Participants With Skin Reactivity, as Assessed Using a 0 (No Reactivity) to 3 (Severe Reactivity) Scale

    Immediately post-dose to 6 hours on Day 1

  • Number of Participants With Adverse Events

    From Screening to Day 85

  • +2 more secondary outcomes

Study Arms (1)

Gantenerumab + Placebo

EXPERIMENTAL

Participants will be randomized to receive gantenerumab HCLF and placebo solution via SC injection according to different sequences for the site of administration and different injection speeds.

Drug: GantenerumabDrug: Placebo

Interventions

GantenerumabDRUG

Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.

Also known as: RO4909832
Gantenerumab + Placebo
PlaceboDRUG

Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.

Gantenerumab + Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female participants (healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, coagulation, serology, and urinalysis)
  • Body mass index between 18.0 and 30.0 kilograms per meter squared (kg/m\^2), inclusive
  • Female participants of childbearing potential must commit to use two acceptable forms of contraception during the study and until at least 6 months after the follow-up visit

You may not qualify if:

  • History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis
  • History or suspicion of drugs of abuse or alcohol addiction
  • Smokers who smoke more than 10 cigarettes per day or equivalent amount of tobacco as determined by history
  • Pregnant or lactating women
  • Positive result on hepatitis B virus (HBV), hepatitis C virus (HCV), or Human immunodeficiency virus (HIV)-1 and -2
  • Any familial history of early onset Alzheimer's disease
  • Prior administration of gantenerumab
  • Participation in an investigational drug medicinal product or medical device study within 90 days before dosing or within seven times the elimination half-life, whichever is longer
  • Any abnormal skin conditions or potentially obscuring tattoos, pigmentation, or lesions in the area intended for SC injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA International Clinical Pharmacology Center (EDS US Clinic)

Lenexa, Kansas, 66219, United States

Location

Related Publications (1)

  • Portron A, Jordan P, Draper K, Muenzer C, Dickerson D, van Iersel T, Hofmann C. A Phase I Study to Assess the Effect of Speed of Injection on Pain, Tolerability, and Pharmacokinetics After High-volume Subcutaneous Administration of Gantenerumab in Healthy Volunteers. Clin Ther. 2020 Jan;42(1):108-120.e1. doi: 10.1016/j.clinthera.2019.11.015. Epub 2019 Dec 26.

    PMID: 31883703DERIVED

MeSH Terms

Interventions

gantenerumab

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2016

First Posted

August 29, 2016

Study Start

August 31, 2016

Primary Completion

March 22, 2017

Study Completion

March 22, 2017

Last Updated

June 11, 2019

Record last verified: 2019-06

Locations

US(1)