Healthy VolunteersPhase 1NCT07271693
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
A Phase 1 study testing RO7806881 in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in New Zealand.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RO7806881
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteNew Zealand
- Study dates
- 22 Dec 2025to 11 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be males or females who are overtly healthy as determined by medical evaluation
- Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m^2) (inclusive)
- Inclusion Criteria Specific to Cohort A9 (East Asian Cohort):
- Must be of ethnic Chinese, Korean, or Japanese origin
- Must have a BW >35 kg and BMI within the range 18-32 kg/m2 (inclusive)
Who cannot join
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment
- History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis
- Latent tuberculosis (TB) or potentially active TB
- Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
- History of hypersensitivity to biologic agents or any of the excipients in the formulation, or other allergy that contraindicates participation in the study
Show all 13Show fewer
- Live vaccines within 1 month of the first screening visit or during the screening period
- Non-live vaccines within 2 weeks prior to dosing
- Previous exposure to RO7806881
- Positive hepatitis C virus (HCV) antibody test result
- Positive test results for hepatitis B infection
- Positive human immunodeficiency virus (HIV) antibody test result
- Positive test result consistent with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BP46089 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research - Christchurch
Christchurch, 8011
About this study
Official title: A Phase I, Randomized, Investigator/Participant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- RO7806881, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7806881Drug
RO7806881 will be administered as per the schedule specified in the protocol.
PlaceboDrug
Placebo will be administered as per the schedule specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7806881: Single Ascending Dose (SAD) | Experimental | Participants will receive single doses of RO7806881, at 8 dose levels across 9 different cohorts (A1-A9) including one optional SAD cohort of East Asian participants (Cohort A9). Receives: Drug: RO7806881 |
| Placebo: SAD | Placebo comparator | Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881. Receives: Drug: Placebo |
| RO7806881: Multiple Ascending Doses (MAD) | Experimental | Participants will receive multiple doses of RO7806881, at 4 dose levels across 4 different cohorts (B1-B4), per the predefined dosing regimen. Receives: Drug: RO7806881 |
| Placebo: MAD | Placebo comparator | Participants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD Part: Number of Participants With Adverse Events (AEs)
Measured: Up to Day 127
MAD Part: Number of Participants With AEs
Measured: Up to Day 162
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)
Measured: Up to Day 127
MAD Part: Number of Participants With DLAEs
Measured: Up to Day 162
Secondary outcomes (10)
SAD and MAD Parts: Serum Concentration of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Dose Proportionality for AUC
Measured: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Dose Proportionality for Cmax
Measured: SAD: Up to Day 127; MAD: Up to Day 162
MAD Part: Accumulation Ratio (Racc) of RO7806881
Measured: Up to Day 162
SAD and MAD Parts: Absolute Bioavailability of RO7806881
Measured: SAD: Up to Day 127; MAD: Up to Day 162
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start22 Dec 2025
- Primary completion11 May 2027 (estimated)
- Study completion11 May 2027 (estimated)
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 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
- NCT07271693
- Sponsor's protocol ID
- BP46089
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Investigator/Participant-blind, Parallel-group, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07271693
- Acronym / sponsor ID
- BP46089
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 11 May 2027 (estimated)
- First posted
- 9 Dec 2025 (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 main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RO7806881: Single Ascending Dose (SAD) | Experimental | Drug: RO7806881Participants will receive single doses of RO7806881, at 8 dose levels across 9 different cohorts (A1-A9) including one optional SAD cohort of East Asian participants (Cohort A9). |
| Placebo: SAD | Placebo comparator | Drug: PlaceboParticipants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881. |
| RO7806881: Multiple Ascending Doses (MAD) | Experimental | Drug: RO7806881Participants will receive multiple doses of RO7806881, at 4 dose levels across 4 different cohorts (B1-B4), per the predefined dosing regimen. |
| Placebo: MAD | Placebo comparator | Drug: PlaceboParticipants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be males or females who are overtly healthy as determined by medical evaluation
- Participants must have body weight (BW) ≥ 40 kilograms (kg) (not applicable to Cohort A9) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m^2) (inclusive)
- Must be of ethnic Chinese, Korean, or Japanese origin
- Must have a BW >35 kg and BMI within the range 18-32 kg/m2 (inclusive)
Key exclusion criteria (13 listed)
- Pregnancy, breastfeeding, or intention to become pregnant during the study or within 6 months after the final dose of study treatment
- History of any clinically significant autoimmune, gastrointestinal, renal, hepatic, pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease; metabolic disorder; cancer or cirrhosis
- Latent tuberculosis (TB) or potentially active TB
- Any major illness within 1 month before the screening examination or any febrile illness within 1 week prior to the screening visit and up to first dose administration
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study
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 |
|---|---|---|
| RO7806881RO7806881 will be administered as per the schedule specified in the protocol. | Drug | RO7806881: Multiple Ascending Doses (MAD), RO7806881: Single Ascending Dose (SAD) |
| PlaceboPlacebo will be administered as per the schedule specified in the protocol. | Drug | Placebo: MAD, Placebo: SAD |
Primary outcome
SAD Part: Number of Participants With Adverse Events (AEs)
Time frame: Up to Day 127
MAD Part: Number of Participants With AEs
Time frame: Up to Day 162
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)
Time frame: Up to Day 127
MAD Part: Number of Participants With DLAEs
Time frame: Up to Day 162
10 secondary outcomes
SAD and MAD Parts: Serum Concentration of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Area Under the Curve (AUC) From the Last Time of Dosing to the Last Measurable Concentration (AUClast) of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Dose Proportionality for AUC
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Dose Proportionality for Cmax
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
MAD Part: Accumulation Ratio (Racc) of RO7806881
Time frame: Up to Day 162
SAD and MAD Parts: Absolute Bioavailability of RO7806881
Time frame: SAD: Up to Day 127; MAD: Up to Day 162
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Reference Study ID Number: BP46089 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
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 RO7806881 in people with Healthy Volunteers, run by Hoffmann-La Roche at 1 site in New Zealand.
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 13 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. 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 New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: BP46089 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SAD Part: Number of Participants With Adverse Events (AEs) (time frame: Up to Day 127). The study lists 4 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 19 Oct 2026.