ISRCTN10993304Active, not recruitingPhase 1
A single-and multiple-dose, open-label, Phase I study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of subcutaneously administered RO7204239 in adult participants with high body weight
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Healthy participants (other than body weight-related conditions) as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- •2. Body weight =90 kilograms (kg) and body mass index (BMI) = 25 kilograms per square meter (kg/m2)
- •3. Must agree to refrain from starting a significant new exercise routine or major change to a previous exercise/diet routine within 4 weeks before screening and to maintain their level of physical activity consistently through study Day 113
Exclusion Criteria
- •1. Presence of clinically significant cardiovascular disease (e.g., cardiac insufficiency, unstable angina, cardiomyopathy, congestive heart failure, or valve disorders or defects)
- •2. Significant allergies to humanized monoclonal antibodies (mAbs)
- •3. Lymphoma, leukemia, or any malignancy within the past 5 years
- •4. Breast cancer within the past 10 years
- •5. Current or chronic history of liver disease or known hepatic or biliary abnormalities
- •6. Gastric bypass surgery
- •7. Any abnormal skin conditions or potentially obscuring pigmentation or lesions in the area intended for SC injection that would prevent visualization of potential injection site reactions (ISRs) to RO7204239
- •8. Use of anti-obesity medications within 6 months prior to enrollment
- •9. Live vaccine(s) within one month before screening or plans to receive live vaccines during the study or within 28 days of the last study treatment administration
- •10. Treatment with biologic agents (such as mAbs including marketed drugs) within 3 months or five half-lives (whichever is longer) prior to dosing
- •11. Presence of hepatitis B surface antigen and/or total hepatitis B core antibody, a positive hepatitis C or human immunodeficiency virus (HIV) antibody test result, and/or evidence of HIV infection at Screening or within 3 months prior to first study treatment administration
Investigators
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