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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorHoffmann-La Roche

About this trial

The main purpose of this study is to evaluate the safety and tolerability of single and multiple ascending doses of RO7806881 in healthy participants.

Eligibility criteria

Qualifiers

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/m²) (inclusive)

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • RO7806881
  • Placebo

Treatment groups

128 Participants
are divided into 4 treatment groups

Sponsors and collaborators