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

NCT07271693 | Recruiting Phase 1

• 1 other identifier: BP46089
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (4)

RO7806881: Single Ascending Dose (SAD)

EXPERIMENTAL

Participants will receive single doses of RO7806881, at 8 dose levels across different cohorts.

Drug: RO7806881

Placebo: SAD

PLACEBO COMPARATOR

Participants will receive single doses of placebo, matched to each of the 8 dose levels of RO7806881.

Drug: Placebo

RO7806881: Multiple Ascending Doses (MAD)

EXPERIMENTAL

Participants will receive multiple doses of RO7806881, at 4 dose levels across different cohorts, per the predefined dosing regimen.

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.

Drug: Placebo

Interventions

RO7806881 DRUG

RO7806881 will be administered as per the schedule specified in the protocol.

RO7806881: Multiple Ascending Doses (MAD); RO7806881: Single Ascending Dose (SAD)

Placebo DRUG

Placebo will be administered as per the schedule specified in the protocol.

Placebo: MAD; Placebo: SAD

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

New Zealand Clinical Research - Christchurch

Christchurch, 8011, New Zealand

RECRUITING

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP46089 https://forpatients.roche.com/

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)