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

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: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: RO7806881; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BP46089 https://forpatients.roche.com/; Phone Number: 888-662-6728; Email: global-roche-genentech-trials@gene.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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) and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m^2) (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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RO7806881: Single Ascending Dose (SAD); Participants will receive single doses of RO7806881, at 8 dose levels across different cohorts.	Drug: RO7806881; RO7806881 will be administered as per the schedule specified in the protocol.
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.
Experimental: RO7806881: Multiple Ascending Doses (MAD); Participants will receive multiple doses of RO7806881, at 4 dose levels across different cohorts, per the predefined dosing regimen.	Drug: RO7806881; RO7806881 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SAD Part: Number of Participants With Adverse Events (AEs)	Up to Day 127
MAD Part: Number of Participants With AEs	Up to Day 162
SAD Part: Number of Participants With Dose-limiting Adverse Events (DLAEs)	Up to Day 127
MAD Part: Number of Participants With DLAEs	Up to Day 162

Secondary Outcome Measures

Outcome Measure	Time Frame
SAD and MAD Parts: Serum Concentration of RO7806881	SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Maximum Concentration (Cmax) of RO7806881	SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Minimum Concentration (Cmin) of RO7806881	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	SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Apparent Total Body Clearance (CL/F) of RO7806881	SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881	SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Dose Proportionality for AUC	SAD: Up to Day 127; MAD: Up to Day 162
SAD and MAD Parts: Dose Proportionality for Cmax	SAD: Up to Day 127; MAD: Up to Day 162
MAD Part: Accumulation Ratio (Racc) of RO7806881	Up to Day 162
SAD and MAD Parts: Absolute Bioavailability of RO7806881	SAD: Up to Day 127; MAD: Up to Day 162

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Actual): December 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID 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