Testing the safety and body effects of RO7806881 in healthy adults
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
This study will test single and multiple doses of RO7806881 in healthy adults to see if the drug is safe and how the body absorbs, distributes, and responds to it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Locations | 1 site (Christchurch) |
| Trial ID | NCT07271693 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, randomized, placebo-controlled study in healthy adult volunteers using single and multiple ascending doses of RO7806881 to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Participants will receive either RO7806881 or placebo and undergo scheduled clinical assessments, vital signs monitoring, laboratory tests, and PK/PD sampling. Dose escalation will proceed based on predefined safety and tolerability criteria. Data will be used to define safe dose ranges and inform dosing for later trials.
Who should consider this trial
Good fit: Healthy adults with body weight ≥40 kg, BMI 18–32 kg/m2, and no clinically significant medical conditions who meet screening criteria are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, have major organ disease, latent or active tuberculosis, recent major illness or fever, or other exclusionary conditions are not eligible and would not receive benefit from participating.
Why it matters
Potential benefit: If successful, the trial could identify safe dose ranges and how RO7806881 behaves in the body, enabling later studies that might benefit patients.
How similar studies have performed: Single- and multiple-ascending-dose Phase 1 PK/PD studies are standard and have successfully supported later development for many drugs, but the clinical benefit of RO7806881 itself is not yet known.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Christchurch
- New Zealand Clinical Research - Christchurch — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: BP46089 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.