NCT04133649

Evaluation of Safety and Tolerability of Libella Gene Therapy for the Treatment of Aging: AAV- hTERT

Evaluation of Safety and Tolerability of Libella Gene Therapy (LGT) for the Treatment of Aging: AAV- hTERT

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Libella Gene Therapeutics · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

Using gene therapy to express active telomerase (hTERT) in humans has the potential to treat many of the age related diseases, including Aging itself. This study will entail treating subjects with hTERT delivered via transduction using AAV. The goal is to extend the telomeres to prevent, delay, or even reverse Aging.

Detailed description

Subjects willing to participate who meet with the inclusion - exclusion criteria, will be treated with a single dose of LGT delivered intravascularly (IV). Baseline will be performed within 8 weeks of beginning the treatment regimen. The treatment regimen will begin with IV delivery of AAV-hTERT, defined as "Day 0." Safety and efficacy analyses will be conducted at Weeks 1, 4, 13, 26, 39, and 52 post-treatment. Study objectives Primary: Safety and Tolerability 1\. Investigate the safety and tolerability of AAV-hTERT by intravenous (IV) administration. Secondary: Provisional Efficacy 1. To determine changes from baseline in hTERT expression, telomerase activity, and telomere length in cells after treatment with AAV-hTERT. 2. To determine changes from baseline in health and aging-related biomarkers after treatment with AAV-hTERT. 3. To determine changes from baseline in the immune system after treatment with AAV-hTERT. 4. To determine changes from baseline in physical function measures after treatment with AAV-hTERT

Conditions

• Aging

Interventions

Type	Name	Description
DRUG	AAV-hTERT	subjects will receive a single LGT (AAV-hTERT) treatment via IV administration

Timeline

• Start date: 2019-10-17
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2019-10-21
• Last updated: 2019-12-10

Locations

1 site across 1 country: Colombia