Clinical Trial

First-In-Human Study to Evaluate Single and Multiple Ascending Doses of JUV-161 in Healthy Adult Volunteers

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2026-04-30 -> 2026-05-30 2026-08-11
minor Completion pushed: 2026-06-30 -> 2026-09-30 2026-08-11
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-21
notable Enrollment increased: 40 -> 72 participants 2026-04-21
Trial Details
NCT Number NCT06918925
Lead Sponsor Juvena Therapeutics
Conditions Healthy Volunteer
Enrollment 72 participants
Start Date 2025-05-14
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-10