An Open-label Study With NVC-001 in Patients With LMNA-related Dilated Cardiomyopathy (SUNBEAM-LMNA)

Conditions

• LMNA-Related Dilated Cardiomyopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NVC-001 - Low Dose — GENETIC
  Solution for intravenous infusion
• NVC-001 - Intermediate Dose — GENETIC
  Solution for intravenous infusion
• NVC-001 - High Dose — GENETIC
  Solution for intravenous infusion

Study Details

This study will be conducted to evaluate the safety and tolerability, and assess exploratory efficacy of NVC-001 in adults participants with LMNA-Related Dilated Cardiomyopathy.

Key Dates

Start date

May 8, 2026

Status verified

May 2026

Primary completion

Mar 31, 2030

Completion

Mar 31, 2030

Study Design

Enrollment

21 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Arms

• Experimental: SAD low dose
  Single Ascending Dose (SAD): participants will receive low dose of NVC-001
• Experimental: SAD medium dose
  Single Ascending Dose (SAD): participants will receive medium dose of NVC-001
• Experimental: SAD high dose
  Single Ascending Dose (SAD): participants will receive high dose of NVC-001

Primary Outcome Measure

Safety as measured by frequency, severity, and relatedness of treatment emergent adverse events (TEAEs) [ Time Frame: At week 26 post dosing ]

Locations (1)

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