A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants

August 20, 2026 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Study Contact Backup

Study Locations

  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • New Zealand Clinical Research - Christchurch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo: SAD
Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881.
Drug: Placebo
Placebo will be administered as per the schedule specified in the protocol.
Placebo Comparator: Placebo: MAD
Participants will receive multiple doses of placebo, matched to each of the 4 dose levels of RO7806881, per the predefined dosing regimen.
Drug: Placebo
Placebo will be administered as per the schedule specified in the protocol.
Experimental: RO7806881: Single Ascending Dose (SAD)
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).
Drug: RO7806881
RO7806881 will be administered as per the schedule specified in the protocol.
Experimental: RO7806881: Multiple Ascending Doses (MAD)
Participants will receive multiple doses of RO7806881, at 4 dose levels across 4 different cohorts (B1-B4), per the predefined dosing regimen.
Drug: RO7806881
RO7806881 will be administered as per the schedule specified in the protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
SAD Part: Number of Participants With Adverse Events (AEs)
Time Frame: Up to Day 127
Up to Day 127
MAD Part: Number of Participants With AEs
Time Frame: Up to Day 162
Up to Day 162
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)
Time Frame: Up to Day 127
Up to Day 127
MAD Part: Number of Participants With DLAEs
Time Frame: Up to Day 162
Up to Day 162

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
SAD and MAD Parts: Serum Concentration of RO7806881
Time Frame: SAD: Up to Day 127; MAD: Up to Day 162
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: 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: 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: 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: 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: 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: 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
SAD: Up to Day 127; MAD: Up to Day 162
MAD Part: Accumulation Ratio (Racc) of RO7806881
Time Frame: Up to Day 162
Up to Day 162
SAD and MAD Parts: Absolute Bioavailability of RO7806881
Time Frame: SAD: Up to Day 127; MAD: Up to Day 162
SAD: Up to Day 127; MAD: Up to Day 162

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP46089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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