drugset / Trial / NCT06918925
First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-04-14
- Primary completion
- 2026-04-30
- Completion
- 2026-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | JUV-161 | Unknown | 0.1 mg/kg | Subcutaneous |
| Comparator | JUV-161 | Unknown | 0.3 mg/kg | Subcutaneous |
| Comparator | JUV-161 | Unknown | 1 mg/kg | Subcutaneous |
| Comparator | JUV-161 | Unknown | 3 mg/kg | Subcutaneous |
| Comparator | JUV-161 | Unknown | 5 mg/kg | Subcutaneous |
| Comparator | JUV-161 | Unknown | 10 mg/kg | Subcutaneous |
Indications
No indication recorded.