HealthyPhase 1NCT03100630
Compare Bioavailability of RO7239361 After Subcutaneous Injection
A Phase 1 study testing RO7239361 in people with Healthy, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RO7239361
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2017to 17 Oct 2017
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
- Body Mass Index 18 kg/m2 to 32 kg/m2
- females must be of non-childbearing potential
Who cannot join
- tattoos or other skin findings on any of the potential injection sites
- history of chronic muscle pain within 30 days prior to study treatment
- prior history of IgG1 therapy
- Other protocol defined inclusion and exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
- Conditions
- Healthy
- Being tested
- RO7239361
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7239361Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: RO7239361 | Active comparator | RO7239361 subcutaneous injections on specified days; abdomen Receives: Drug: RO7239361 |
| Treatment B: RO7239361 | Active comparator | RO7239361 subcutaneous injections on specified days; arm Receives: Drug: RO7239361 |
| Treatment C: RO7239361 | Active comparator | RO7239361 subcutaneous injections on specified days; thigh Receives: Drug: RO7239361 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum concentration (Cmax)
Measured: Up to 92 days
AUC from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to 92 days
AUC from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to 92 days
Secondary outcomes (5)
Incidence of Adverse Events ( AEs)
Measured: Up to 92 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 92 days
Change from baseline in electrocardiogram findings
Measured: Up to 92 days
Change from baseline in physical examination findings
Measured: Up to 92 days
Change from baseline in clinical laboratory test findings
Measured: Up to 92 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start9 May 2017
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 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
- NCT03100630
- Sponsor's protocol ID
- CN001-023
- Other IDs
- WP40225
- Status last verified
- Aug 2019
- First submitted
- 29 Mar 2017
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants
- ClinicalTrials.gov ID
- NCT03100630
- Acronym / sponsor ID
- CN001-023
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 May 2017 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A: RO7239361 | Active comparator | Drug: RO7239361RO7239361 subcutaneous injections on specified days; abdomen |
| Treatment B: RO7239361 | Active comparator | Drug: RO7239361RO7239361 subcutaneous injections on specified days; arm |
| Treatment C: RO7239361 | Active comparator | Drug: RO7239361RO7239361 subcutaneous injections on specified days; thigh |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments
- Body Mass Index 18 kg/m2 to 32 kg/m2
- females must be of non-childbearing potential
Key exclusion criteria (4 listed)
- tattoos or other skin findings on any of the potential injection sites
- history of chronic muscle pain within 30 days prior to study treatment
- prior history of IgG1 therapy
- Other protocol defined inclusion and exclusion criteria apply
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 |
|---|---|---|
| RO7239361Specified dose on specified days | Drug | Treatment A: RO7239361, Treatment B: RO7239361, Treatment C: RO7239361 |
Primary outcome
Maximum observed serum concentration (Cmax)
Time frame: Up to 92 days
AUC from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to 92 days
AUC from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to 92 days
5 secondary outcomes
Incidence of Adverse Events ( AEs)
Time frame: Up to 92 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 92 days
Change from baseline in electrocardiogram findings
Time frame: Up to 92 days
Change from baseline in physical examination findings
Time frame: Up to 92 days
Change from baseline in clinical laboratory test findings
Time frame: Up to 92 days
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 7 Aug 2019.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 RO7239361 in people with Healthy, 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 3 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 7 Aug 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. 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?
Maximum observed serum concentration (Cmax) (time frame: Up to 92 days). The study lists 3 primary outcomes in all. 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 7 Aug 2019.