Healthy VolunteerPhase 1NCT02427243
A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose
A Phase 1 study testing Crenezumab in people with Healthy Volunteer, run by Genentech, Inc. at 2 sites in United States.
Trial summary
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Crenezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Jul 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female 18 to 65 years of age at Screening, inclusive
- Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive
- Body weight 50 to 100 kg, inclusive
- Females must be of non-childbearing potential
- Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later
Who cannot join
- Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)
- History of alcoholism or drug addiction within 6 months prior to CRU Check-in
- Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Dallas, Texas, 75247
Study site
Evansville, Indiana, 47710
About this study
Official title: A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- Crenezumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrenezumabDrug
Also called RO5490245 or MABT5102A (formerly)
CrenezumabDrug
Also called RO5490245 or MABT5102A (formerly)
| Study group | Role | What they receive |
|---|---|---|
| Crenezumab Formulation 2 | Experimental | A single dose given as two subcutaneous injections on Day 1 Receives: Drug: Crenezumab |
| Crenezumab Formulation 3 | Experimental | A single dose given as two subcutaneous injections on Day 1 Receives: Drug: Crenezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)
Measured: Day 1 through Day 85 or early termination
Secondary outcomes (2)
Incidence, nature, and severity of adverse events
Measured: Consent through Day 85 or early termination
Incidence of anti-therapeutic antibodies (ATAs) to crenezumab
Measured: From Day 1 (Predose) through Day 85 or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
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 Genentech, Inc.The 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427243
- Sponsor's protocol ID
- GP29172
- Status last verified
- Nov 2016
- First submitted
- 22 Apr 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose, Randomized, Open-Label, Parallel Group Study to Assess the Relative Bioavailability and Tolerability of Two Formulations of Crenezumab in Healthy Subjects Following Subcutaneous Administration
- ClinicalTrials.gov ID
- NCT02427243
- Acronym / sponsor ID
- GP29172
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Apr 2015 (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.
To assess the relative bioavailability and tolerability of two different formulations of crenezumab in approximately 60 healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crenezumab Formulation 2 | Experimental | Drug: CrenezumabA single dose given as two subcutaneous injections on Day 1 |
| Crenezumab Formulation 3 | Experimental | Drug: CrenezumabA single dose given as two subcutaneous injections on Day 1 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female 18 to 65 years of age at Screening, inclusive
- Body mass index (BMI) 18.5 to 32 kg/m^2, inclusive
- Body weight 50 to 100 kg, inclusive
- Females must be of non-childbearing potential
- Males of reproductive potential must agree to remain abstinent or must be using highly effective contraception and must avoid sperm donation, from Screening until at least 8 weeks after the last study drug administration or until study completion, whichever is later
Key exclusion criteria (4 listed)
- Significant medical history, psychiatric disorder, or acute infection at Screening (as determined by Investigator)
- History of alcoholism or drug addiction within 6 months prior to CRU Check-in
- Use of tobacco or nicotine-containing products from 6 months prior to CRU Check-in and during the study
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred wtihin 30 days or 5 half-lives, whichever is longer, prior to CRU Check-in
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 |
|---|---|---|
| CrenezumabAlso: RO5490245 or MABT5102A (formerly) | Drug | Crenezumab Formulation 3 |
| CrenezumabAlso: RO5490245 or MABT5102A (formerly) | Drug | Crenezumab Formulation 2 |
Primary outcome
Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2)
Time frame: Day 1 through Day 85 or early termination
2 secondary outcomes
Incidence, nature, and severity of adverse events
Time frame: Consent through Day 85 or early termination
Incidence of anti-therapeutic antibodies (ATAs) to crenezumab
Time frame: From Day 1 (Predose) through Day 85 or early termination
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 2 Nov 2016.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Crenezumab in people with Healthy Volunteer, run by Genentech, Inc. at 2 sites 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 5 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Pharmacokinetic (PK) profile of crenezumab (Cmax, tmax, AUC0-last, AUC(0-infinity), Vz/F, CL/F, Apparent terminal elimination rate constant, and t1/2) (time frame: Day 1 through Day 85 or early termination). 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 2 Nov 2016.