A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7806881 in Healthy Participants
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.
Key facts
- Study ID
- NCT07271693
- Run by
- Hoffmann-La Roche
- People needed
- 128
- Starts
- 2025-12-22
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
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) (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)
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)
Where it is running
- New Zealand Clinical Research - Christchurch — Christchurch, New Zealand (enrolling)
Full record on ClinicalTrials.gov
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