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
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
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- 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