A study to evaluate the safety, tolerability, processing by the body, and response of the body to the drug RO7497987 in single and multiple ascending doses in healthy volunteers
Phase 1
Completed
- Conditions
- Safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497987Not Applicable
- Registration Number
- ISRCTN92655801
- Lead Sponsor
- Roche (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1. Age =18 years and =65 years at the time of signing Informed Consent Form (ICF)
2. A minimum weight of 40 kg at screening
3. Body mass index of 18-32 kg/m² at screening
4. Adequate hematologic and end-organ function
Exclusion Criteria
1. History or active diseases of bone marrow disorders
2. History of malignancy within 5 years prior to screening
3. Vaccine immunization within 2 weeks prior to initiation of study drug
4. Known infection/COVID-19 positive or persistent symptoms of SARS-CoV-2
5. HIV positive
6. Active Hepatitis B or Hepatitis C infections
7. Current tobacco use
8. History or currently active of autoimmune disease
9. Significant cardiovascular disease
10. Known clinically significant liver and renal diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method