Testing the safety and body effects of RO7806881 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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)

Where it's running

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

Study contacts

• Study coordinator: Reference Study ID Number: BP46089 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.