Healthy volunteers Other
Conditions
Interventions
Group 1: Participants will receive a single dose of RO7204239, as a subcutaneous (SC) injection on Day 1.
Group 2: Participants will receive multiple doses of RO7204239, as SC injection, every 2 wee
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 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 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
| Measure | Time frame |
|---|---|
| 1. Maximum observed concentration (Cmax) of RO7204239 assessed using non-compartmental methods from the plasma samples collected at pre-dose and multiple time points post-dose from Day 1 up to Day 253 for Group 1 and from Day 1 up to Day 337 for Group 2 2. Area under the serum concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast) of RO7204239 assessed using non-compartmental methods from the plasma samples collected at pre-dose and multiple time points post-dose from Day 1 up to Day 253 for Group 1 3. AUC from single dosing time extrapolated to infinity (AUCinf) of RO7204239 assessed using non-compartmental methods from the plasma samples collected at pre-dose and multiple time points post-dose from Day 1 up to Day 253 for Group 1 4. AUC over a dosing interval (AUCtau) of RO7204239 assessed using non-compartmental methods from the plasma samples collected at pre-dose and multiple time points post-dose from Day 1 up to Day 337 for Group 2 5. Absolute levels of total latent myostatin, free latent myostatin and total mature myostatin measured from the serum samples collected at pre-dose and multiple time points post-dose from Day -1 up to Day 253 for Group 1 and from Day -1 up to Day 337 for Group 2 6. Change from baseline in levels of total latent myostatin, free latent myostatin and total mature myostatin measured from the serum samples collected at pre-dose and multiple time points post-dose from Day -1 up to Day 253 for Group 1 and from Day -1 up to Day 337 for Group 2 7. Number of participants with anti-drug antibodies (ADAs) to RO7204239 as measured using plasma samples collected from Day 1 up to Day 253 for Group 1 and Day 1 up to Day 337 for Group 2 | — |
Countries
New Zealand
Contacts
Public ContactClinical Trials
Outcome results
None listed