Healthy
Conditions
Brief summary
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.
Interventions
DRUGRO7239361
Specified dose on specified days
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments * Body Mass Index 18 kg/m2 to 32 kg/m2 * females must be of non-childbearing potential
Exclusion criteria
* tattoos or other skin findings on any of the potential injection sites * history of chronic muscle pain within 30 days prior to study treatment * prior history of IgG1 therapy Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration (Cmax) | Up to 92 days |
| AUC from time zero to time of last quantifiable concentration [AUC(0-T)] | Up to 92 days |
| AUC from time zero extrapolated to infinite time [AUC(INF)] | Up to 92 days |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in physical examination findings | Up to 92 days |
| Incidence of Adverse Events ( AEs) | Up to 92 days |
| Change from baseline in clinical laboratory test findings | Up to 92 days |
| Incidence of Serious Adverse Events (SAEs) | Up to 92 days |
| Change from baseline in electrocardiogram findings | Up to 92 days |
Countries
United States
Outcome results
None listed