Healthy volunteers Other
Conditions
Interventions
Current interventions as of 11/03/2025:
Single Ascending Dose (SAD) part: Participants will receive a single dose of RO7504109 or a matching placebo, as IV infusion or SC injection, on Day 1.
Multi
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy participants with body mass index (BMI) of 18 to 32 kilograms per metre squared (kg/m2) inclusive and a body weight of =50 kg at Screening. 2. Female participants of childbearing potential (POCBP) are eligible to participate if not pregnant, not breastfeeding, and agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method during the treatment period. 3. Male Participants must, during the treatment period at least 90 days after the last dose of study treatment, agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures. 4. Participants who are overtly healthy determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), or vital signs.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 11/03/2025: 1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease (including stable asthma and childhood asthma), metabolic disorder, cancer (within the last 5 years), or cirrhosis. 2. History of tuberculosis or a positive QuantiFERON Gold test. 3. Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drugs of abuse. 4. Positive test (positive antibody or antigen confirmed with positive polymerase chain reaction [PCR]) result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficient virus (HIV) 1 and 2. 5. Positive test result (positive immunoglobulin [Ig]G and IgM) for cytomegalovirus or Epstein-Barr virus unless documented resolution of the disease. 6. Clinically significant joint problems including but not limited to ongoing pain or swelling that in the opinion of the Investigator, pose an unacceptable risk to the participant in this study. _____ Previous exclusion criteria: 1. History of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, or allergic disease (including stable asthma and childhood asthma), metabolic disorder, cancer, or cirrhosis. 2. History of tuberculosis or a positive QuantiFERON Gold test. 3. Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drugs of abuse. 4. Positive test (positive antibody or antigen confirmed with positive PCR) result for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficient virus (HIV) 1 and 2. 5. Positive test result (positive immunoglobulin [Ig]G and IgM) for cytomegalovirus or Epstein-Barr virus unless documented resolution of the disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 11/03/2025: 1. SAD part and MAD part: Number of participants with adverse events (AEs) and severity of AEs graded according to the National Cancer Institute common terminology criteria for adverse events version 5.0 (NCI CTCAE v5.0) up to 155 days for the SAD part and up to 211 days for the MAD part 2. SAD part and MAD part: Number of participants with dose-limiting adverse events (DLAEs) as assessed and recorded by the investigator on the electronic case report form (eCRF) from Day 1 up to Day 15 for the SAD part and from Day 1 up to Day 44 for the MAD part 3. SAD Part and MAD Part: RO7504109 serum concentration after single or multiple IV or SC doses assessed using validated assays at multiple time points on Day 1 up to Day 155 for the SAD part and multiple time points on Day 1, up to Day 211 for the MAD part 4. SAD part: Dose proportionality of RO7504109 measured using the linear model at multiple time points on Day 1 up to Day 155 5. MAD part: Dose proportionality of RO7504109 measured using linear mixed effect model assessed at multiple time points on Day 1 up to Day 211 6. MAD part: Accumulation index after multiple IV or SC doses of RO7504109 measured using linear mixed effect model assessed at multiple time points on Day 1 up to Day 57 7. SAD part and MAD part: Area under the plasma concentration (AUC) curve of RO7504109 measured using standard non-compartmental methods at multiple time points on Day 1 up to Day 155 for the SAD part and multiple time points on Day 1 up to Day 211 for the MAD part 8. MAD part: Minimum plasma concentration (Cmin) of RO7504109 measured using standard non-compartmental methods at multiple time points on Day 1 up to Day 211 for the MAD part 9. SAD part and MAD part: Maximum plasma concentration (Cmax) of RO7504109 measured using standard non-compartmental methods at multiple time points on Day 1 up to Day 155 for the SAD part and multiple time points on Day 1 up to Day 211 for the MAD part | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary endpoints | — |
Countries
New Zealand
Contacts
Public ContactClinical Trials
Outcome results
None listed