First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers
Trial Parameters
Brief Summary
The present First-In-Human (FIH) study (JUV-161-101) aims to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of JUV-161 in healthy volunteers. The study design is well-established for FIH studies and appropriate to assess the preliminary safety and tolerability of new drug candidates. Data from this study will support conduct studies in patients with DM1 as well as supporting studies in other degenerative myopathies and other disorders for which preclinical efficacy data have been obtained.JUV-161 has not been previously been administered to human subjects.
Eligibility Criteria
Inclusion Criteria: 1. Are males or nonpregnant females, ages 18 to 60 (inclusive) at time of signing Informed Consent with body mass index (BMI) 18 to 35 kg/m2 2. Are willing and able to give informed consent and follow all study procedures and requirements 3. Are able to understand the requirements of the study protocol 4. Agree to complete all required study visits 5. Are healthy, based on physical examination, medical history laboratory tests, vital signs and resting electrocardiograms 6. Are willing to abstain from caffeine and nicotine while in the Study Unit 7. Have negative screens for alcohol and drugs of abuse at screening and admission 8. Are willing to abstain from all alcoholic beverages and cannabinoids for 48 h prior to dosing through Post-dosing visit on Study Day 6. 9. Females must be either: * of non-childbearing potential (defined as having undergone surgical sterilization (hysterectomy, bilateral salpingectomy, bilateral oophorectomy or being postmenopausal (i.e., g