Healthy VolunteerPhase 1NCT02711423
A Single-Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Gantenerumab Following Subcutaneous (SC) Administration in Healthy Volunteers
A Phase 1 study testing Gantenerumab in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2016to 28 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males 18 to 45 years of age, inclusive
- Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m^2), inclusive
Who cannot join
- History of cancer or any clinically significant disease affecting one of the major organ systems
- Prior administration of gantenerumab
- Clinically significant laboratory test results
- Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent
- Known hypersensitivity to gantenerumab or excipients of study drug formulation
- Abnormal skin condition or potentially obscuring tattoo, pigmentation, or lesion in the area intended for SC injection
- Familial history of early-onset Alzheimer's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.
- 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
Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
PlaceboDrug
Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Part I (Dose Escalation): Gantenerumab | Experimental | Participants will receive a single SC dose of gantenerumab on Day 1. Receives: Drug: Gantenerumab |
| Part I (Dose Escalation): Placebo | Placebo comparator | Participants will receive a single SC dose of matching placebo on Day 1. Receives: Drug: Placebo |
| Part II (PK Extension): Gantenerumab | Experimental | Participants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I. Receives: Drug: Gantenerumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with adverse events (AEs)
Measured: Up to 12 weeks (from Baseline to Day 85 +/- 5 days)
Secondary outcomes (2)
Maximum observed plasma concentration (Cmax) of gantenerumab
Measured: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Area under the plasma concentration-time curve (AUC) of gantenerumab
Measured: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start31 Mar 2016
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
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
- NCT02711423
- Sponsor's protocol ID
- BP30042
- Other IDs
- 2015-005132-17, 2015
- Status last verified
- Apr 2019
- First submitted
- 14 Mar 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Investigator/Subject-Blind Single-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Gantenerumab Following SC Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02711423
- Acronym / sponsor ID
- BP30042
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This two-part study is designed to assess the safety, tolerability, and PK of gantenerumab in healthy volunteers. Part I (dose escalation) will randomly assign participants to receive a single blinded SC dose of gantenerumab or placebo. Part II (PK extension) will randomly assign participants to receive a single open-label SC dose of ganenerumab at different dose levels according to safety assessments from Part I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part I (Dose Escalation): Gantenerumab | Experimental | Drug: GantenerumabParticipants will receive a single SC dose of gantenerumab on Day 1. |
| Part I (Dose Escalation): Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single SC dose of matching placebo on Day 1. |
| Part II (PK Extension): Gantenerumab | Experimental | Drug: GantenerumabParticipants will receive a single SC dose of gantenerumab on Day 1. The dose range will be determined by safety and tolerability data collected from Part I. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males 18 to 45 years of age, inclusive
- Body mass index (BMI) 20.0 to 32.0 kilograms per meter-squared (kg/m^2), inclusive
Key exclusion criteria (7 listed)
- History of cancer or any clinically significant disease affecting one of the major organ systems
- Prior administration of gantenerumab
- Clinically significant laboratory test results
- Clinically relevant history of hypersensitivity or allergic reaction following exposure to a drug, food, or environmental agent
- Known hypersensitivity to gantenerumab or excipients of study drug formulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GantenerumabGantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1. | Drug | Part I (Dose Escalation): Gantenerumab, Part II (PK Extension): Gantenerumab |
| PlaceboPlacebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1. | Drug | Part I (Dose Escalation): Placebo |
Primary outcome
Percentage of participants with adverse events (AEs)
Time frame: Up to 12 weeks (from Baseline to Day 85 +/- 5 days)
2 secondary outcomes
Maximum observed plasma concentration (Cmax) of gantenerumab
Time frame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Area under the plasma concentration-time curve (AUC) of gantenerumab
Time frame: Predose (0 hours) and 1, 6, and 12 hours from single dose administration; once daily from Days 2 to 10; and once daily on Days 12, 15, 21, 29, 43, 64, and 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gantenerumab in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with adverse events (AEs) (time frame: Up to 12 weeks (from Baseline to Day 85 +/- 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.