Healthy Volunteers
Conditions
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.
Interventions
DRUGRO7806881
RO7806881 will be administered as per the schedule specified in the protocol.
DRUGPlacebo
Placebo will be administered as per the schedule specified in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| SAD and MAD Parts: Volume of Distribution at Steady-state Conditions (Vss) of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Dose Proportionality for AUC | SAD: Up to Day 127; MAD: Up to Day 162 |
| SAD and MAD Parts: Dose Proportionality for Cmax | SAD: Up to Day 127; MAD: Up to Day 162 |
| MAD Part: Accumulation Ratio (Racc) of RO7806881 | Up to Day 162 |
| SAD and MAD Parts: Absolute Bioavailability of RO7806881 | SAD: Up to Day 127; MAD: Up to Day 162 |
Countries
New Zealand
Contacts
CONTACTReference Study ID Number: BP46089 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed