A study to find out the safety, tolerability and processing of RO7204239 by the body, the effect of RO7204239 on the body in participants with high body weight
- Conditions
- Healthy volunteersNot Applicable
- Registration Number
- ISRCTN10993304
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of participants with treatment-emergent adverse events (AEs) and severity of TEAEs assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) from Day 1 up to Day 253 for Group 1 and from Day 1 up to Day 337 for Group 2 <br>2. Number of participants with local and systemic injection reactions assessed using data collected in the electronic case report form (eCRF) from Day 1 up to Day 253 for Group 1 and from Day 1 up to Day 337 for Group 2 <br>3. Number of participants with local injection site pain measured on a 10-point numerical rating scale, completed by participants at multiple timepoints on Day 1 for Group 1 and from Day 1 up to Day 85 for Group 2 <br>4. Number of participants with local injection site pruritus measured on a 10-point numerical rating scale, completed by participants at multiple timepoints on Day 1 for Group 1 and from Day 1 up to 85 for Group 2
- Secondary Outcome Measures
Name Time Method