Compare Bioavailability of RO7239361 After Subcutaneous Injection
- Registration Number
- NCT03100630
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
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 exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment C: RO7239361 RO7239361 RO7239361 subcutaneous injections on specified days; thigh Treatment A: RO7239361 RO7239361 RO7239361 subcutaneous injections on specified days; abdomen Treatment B: RO7239361 RO7239361 RO7239361 subcutaneous injections on specified days; arm
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 Change from baseline in physical examination findings Up to 92 days Incidence of Adverse Events ( AEs) Up to 92 days
Trial Locations
- Locations (1)
WCCT Global, Inc.
🇺🇸Cypress, California, United States