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

NCT06918925 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

JUV-161, Placebo

Single-Ascending, Placebo-Controlled

Sponsors & Collaborators

  • Juvena Therapeutics

    lead INDUSTRY

Principal Investigators

  • Philip Ryan, MD · Nucleus Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-14
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06918925 on ClinicalTrials.gov