Healthy VolunteerPhase 1NCT02882009
A Study to Assess the Impact of Speed and Site of Subcutaneous Injection on Pain, Tolerability, Safety, and Pharmacokinetics of Gantenerumab in Healthy Participants
A Phase 1 study testing Gantenerumab in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Gantenerumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2016to 22 Mar 2017
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA International Clinical Pharmacology Center (EDS US Clinic)
Lenexa, Kansas, 66219
About this study
Official title: A Single-Center, Randomized, Open-Label, Parallel-Group, Placebo-Controlled, Cross-Over Study To Investigate the Impact of Speed of Injection and Site of Injection on Pain, Tolerability, Safety, and Pharmacokinetics Following Subcutaneous Administration of Gantenerumab in Healthy Volunteers
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.
- Conditions
- Healthy Volunteer
- Being tested
- Gantenerumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GantenerumabDrug
Also called RO4909832
Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.
PlaceboDrug
Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gantenerumab; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Pain as Assessed Using Visual Analog Scale (VAS)
Measured: 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
Measured: 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])
Measured: 0 to 20 minutes after injection on Day 1
Local Pain as Assessed Using Verbal Rating Scale (VRS) Score
Measured: 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
Measured: Immediately post-dose to 6 hours on Day 1
Number of Participants With Adverse Events
Measured: From Screening to Day 85
Number of Participants With Anti-Gantenerumab Antibodies (ADAs)
Measured: Day 1 (predose [Hour 0]) and Day 85
Maximum Observed Plasma Concentration (Cmax) of Gantenerumab
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start31 Aug 2016
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882009
- Sponsor's protocol ID
- WP39322
- Status last verified
- Jun 2019
- First submitted
- 24 Aug 2016
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 31883703