Healthy VolunteersPhase 1NCT04605718
A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants
A Phase 1 study testing RO7223280 in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RO7223280
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2020to 9 Mar 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parts 1 (SAD) and 2 (MAD): 18 to 64 years of age, inclusive. Part 3 (Elderly): 65 years of age and older
- Healthy participants in Part 1 (SAD) and Part 2 (MAD). Health status is defined by 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 ECG, hematology, blood chemistry, serology, coagulation, and urinalysis. Healthy participants in Part 3 (Elderly). Participants must be in reasonably good health as determined by the Investigator based on medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology,blood chemistry, serology, coagulation, and urinalysis. Participants with mild, chronic, stable disease (e.g., controlled hypertension, controlled diabetes mellitus) may be enrolled if deemed medically prudent by the Investigator.
- In Part 1 (SAD) and Part 2 (MAD) participants must weigh at least 50 kg and must have a body mass index (BMI) within the range of 18 to 32 kg/m^2 (inclusive). In Part 3 (Elderly), participants must weigh at least 50 kg with no restrictions regarding the BMI.
- During the treatment period and for at least 90 days after the final dose of RO7223280 or placebo, male participants (whether surgically sterilized or not) agree to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm at least 90 days after last dose.
Who cannot join
- For Part 1 (SAD) and Part 2 (MAD), history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis.For Part 3 (elderly), participants must be in reasonably good health as determined by the Investigator based on a detailed medical history. Participants with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the Investigator.
- In Part 1 (SAD) and Part 2 (MAD), use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer), prior to Day 1. In Part 3 (Elderly Cohort), the systemic use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer), prior to Day 1.
- Participation in an investigational drug medicinal product or medical device study within 30 days prior to screening or within 5 times the elimination half-life if known, whichever is longer.
- In Part 1 (SAD) and Part 2 (MAD), confirmed (based on the average of 3 consecutive measurements) systolic blood pressure (SBP) greater than 140 or less than 90 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mmHg at screening. In Part 3 (Elderly), confirmed (based on the average of 3 consecutive measurements) systolic blood pressure (SBP) greater than 160 or less than 80 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 40 mmHg at screening.
- Confirmed (based on the average of 3 consecutive measurements) resting pulse greater than 100 bpm or less than 40 bpm at screening.
- Positive for HIV or Hepatitis B/C infections.
- Donation of blood or blood products for transfusion over 500 mL within 3 months prior to first study drug administration and for the duration of the study.
- Any clinically significant history of hypersensitivity or allergic reactions, either spontaneous or following study drug administration, or from exposure to food or environmental agents.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc
Madison, Wisconsin, 53704
About this study
Official title: A Randomized, Sponsor-Open, Adaptive, Single- And Multiple-Ascending Dose, Placebo-Controlled Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of RO7223280 Following Intravenous Administration In Healthy Participants
The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, tolerability and PK of multiple-ascending IV doses of RO7223280 in healthy participants. Part 2 will start after the initial completion of Part 1 (SAD). Progression from Part 1 to Part 2 will be based on a satisfactory review of all available safety, tolerability, and PK data by the Investigator and the Sponsor from Part 1. The starting dose for Part 2 will be administered as 1-hour IV infusion; as it has been established on the basis of all available safety, tolerability, and PK data in Part 1 (SAD). Part 3 will investigate the safety, tolerability and PK of a single IV dose of RO7223280 in healthy elderly participants. A single IV dose of RO7223280 administered over 1 hour was selected, within the range of previously explored doses in Part 1 (SAD).
- Conditions
- Healthy Volunteers
- Being tested
- RO7223280
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7223280Drug
For Part 1 (SAD) and Part 2 (MAD), RO7223280 will be administered by intravenous (IV) infusion at escalating doses from 10mg to 4800mg, as per the dosing schedules described above. These are putative doses and the maximum daily dose that must not be exceeded is 5000mg. For Part 3 (Elderly), RO7223280 will be administer as one single IV dose of 300 mg.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (SAD) | Experimental | Due to mandatory sentinel dosing, participants will be divided into two groups: 2 participants will be dosed on one day (sentinel group with 1 on active treatment and 1 on placebo) and remaining participants of the dose cohort (randomized as 5 on active treatment and 1 on placebo) at the earliest 24 hours after the first dosing occasion. Receives: Drug: RO7223280 |
| Part 2 (MAD) | Experimental | In each dose cohort, a minimum of 4 participants and a maximum of 12 participants will receive either multiple IV doses of RO72232809 or placebo once-daily for 10 days (3:1 ratio of active:placebo treatment). Receives: Drug: RO7223280 |
| Part 3 (Elderly) | Experimental | In this cohort, a minimum of 4 participants and a maximum of 12 participants will receive a single IV dose of RO7223280 or placebo (3:1 ratio of active:placebo treatment). Receives: Drug: RO7223280 |
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 19 months
Secondary outcomes (2)
Plasma Concentrations of RO7223280 at specified timepoints
Measured: Up to 19 months
Urine Concentrations of RO7223280 at specified timepoints
Measured: Up to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start7 Dec 2020
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 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
- NCT04605718
- Sponsor's protocol ID
- BP41732
- Status last verified
- Apr 2023
- First submitted
- 23 Oct 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sponsor-Open, Adaptive, Single- And Multiple-Ascending Dose, Placebo-Controlled Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of RO7223280 Following Intravenous Administration In Healthy Participants
- ClinicalTrials.gov ID
- NCT04605718
- Acronym / sponsor ID
- BP41732
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 28 Oct 2020 (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.
The Study consists of 3 Parts: Part 1 (Single Ascending Dose/SAD), Part 2 (Multiple Ascending Dose/MAD), and Part 3 (Elderly). Part 1 will investigate the safety, tolerability and PK of single-ascending intravenous (IV) doses of RO7223280 in healthy participants. Part 2 will investigate the safety, tolerability and PK of multiple-ascending IV doses of RO7223280 in healthy participants. Part 2 will start after the initial completion of Part 1 (SAD). Progression from Part 1 to Part 2 will be based on a satisfactory review of all available safety, tolerability, and PK data by the Investigator and the Sponsor from Part 1. The starting dose for Part 2 will be administered as 1-hour IV infusion; as it has been established on the basis of all available safety, tolerability, and PK data in Part 1 (SAD). Part 3 will investigate the safety, tolerability and PK of a single IV dose of RO7223280 in healthy elderly participants. A single IV dose of RO7223280 administered over 1 hour was selected, within the range of previously explored doses in Part 1 (SAD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 (SAD) | Experimental | Drug: RO7223280Due to mandatory sentinel dosing, participants will be divided into two groups: 2 participants will be dosed on one day (sentinel group with 1 on active treatment and 1 on placebo) and remaining participants of the dose cohort (randomized as 5 on active treatment and 1 on placebo) at the earliest 24 hours after the first dosing occasion. |
| Part 2 (MAD) | Experimental | Drug: RO7223280In each dose cohort, a minimum of 4 participants and a maximum of 12 participants will receive either multiple IV doses of RO72232809 or placebo once-daily for 10 days (3:1 ratio of active:placebo treatment). |
| Part 3 (Elderly) | Experimental | Drug: RO7223280In this cohort, a minimum of 4 participants and a maximum of 12 participants will receive a single IV dose of RO7223280 or placebo (3:1 ratio of active:placebo treatment). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parts 1 (SAD) and 2 (MAD): 18 to 64 years of age, inclusive. Part 3 (Elderly): 65 years of age and older
- Healthy participants in Part 1 (SAD) and Part 2 (MAD). Health status is defined by 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 ECG, hematology, blood chemistry, serology, coagulation, and urinalysis. Healthy participants in Part 3 (Elderly). Participants must be in reasonably good health as determined by the Investigator based on medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology,blood chemistry, serology, coagulation, and urinalysis. Participants with mild, chronic, stable disease (e.g., controlled hypertension, controlled diabetes mellitus) may be enrolled if deemed medically prudent by the Investigator.
- In Part 1 (SAD) and Part 2 (MAD) participants must weigh at least 50 kg and must have a body mass index (BMI) within the range of 18 to 32 kg/m^2 (inclusive). In Part 3 (Elderly), participants must weigh at least 50 kg with no restrictions regarding the BMI.
- During the treatment period and for at least 90 days after the final dose of RO7223280 or placebo, male participants (whether surgically sterilized or not) agree to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm at least 90 days after last dose.
Key exclusion criteria (8 listed)
- For Part 1 (SAD) and Part 2 (MAD), history of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological or allergic disease, metabolic disorder, cancer, or cirrhosis.For Part 3 (elderly), participants must be in reasonably good health as determined by the Investigator based on a detailed medical history. Participants with mild, chronic, stable disease and on stable medication may be enrolled if deemed medically prudent by the Investigator.
- In Part 1 (SAD) and Part 2 (MAD), use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer), prior to Day 1. In Part 3 (Elderly Cohort), the systemic use of glucocorticoids and other immunosuppressive medications is prohibited within 30 days (or within 5 times the elimination half-life, whichever is longer), prior to Day 1.
- Participation in an investigational drug medicinal product or medical device study within 30 days prior to screening or within 5 times the elimination half-life if known, whichever is longer.
- In Part 1 (SAD) and Part 2 (MAD), confirmed (based on the average of 3 consecutive measurements) systolic blood pressure (SBP) greater than 140 or less than 90 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mmHg at screening. In Part 3 (Elderly), confirmed (based on the average of 3 consecutive measurements) systolic blood pressure (SBP) greater than 160 or less than 80 mmHg, and diastolic blood pressure (DBP) greater than 90 or less than 40 mmHg at screening.
- Confirmed (based on the average of 3 consecutive measurements) resting pulse greater than 100 bpm or less than 40 bpm at screening.
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 |
|---|---|---|
| RO7223280For Part 1 (SAD) and Part 2 (MAD), RO7223280 will be administered by intravenous (IV) infusion at escalating doses from 10mg to 4800mg, as per the dosing schedules described above. These are putative doses and the maximum daily dose that must not be exceeded is 5000mg. For Part 3 (Elderly), RO7223280 will be administer as one single IV dose of 300 mg. | Drug | Part 1 (SAD), Part 2 (MAD), Part 3 (Elderly) |
Primary outcome
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 19 months
2 secondary outcomes
Plasma Concentrations of RO7223280 at specified timepoints
Time frame: Up to 19 months
Urine Concentrations of RO7223280 at specified timepoints
Time frame: Up to 19 months
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 18 Apr 2023.
- Individual participant dataSharing planned: No. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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 RO7223280 in people with Healthy Volunteers, 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 4 inclusion and 8 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 18 Apr 2023. 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?
Percentage of Participants with Adverse Events (AEs) (time frame: Up to 19 months). 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 18 Apr 2023.