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Recruiting EARLY_Phase 1 NCT07285629

Safety and Efficacy of Klotho and Follistatin Gene Therapy

Trial Parameters

Condition Healthy Adults
Sponsor Minicircle
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 30
Sex ALL
Min Age 50 Years
Max Age 80 Years
Start Date 2025-12-16
Completion 2026-06
Interventions
Follistatin and klotho gene therapy

Brief Summary

The purpose of this study is to investigate the safety and efficacy of a combination klotho and follistatin gene therapy, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to understand the cognitive and health benefits of this gene therapy.

Eligibility Criteria

Inclusion Criteria: * Adults aged 50 to 80 years * General good health * Willing to comply with all study-related procedures and visits * Participant is open to morphological change * If female, participant agrees to maintain contraception * If female, participant agrees to take a pregnancy test * If female, participant agrees to a pregnancy waiver Exclusion Criteria: * Currently enrolled in another clinical trial * History of cancer, autoimmune disease, or chronic kidney/liver disease * Use of immunosuppressive therapy * Pregnant or breastfeeding * Women of childbearing potential who are unwilling or unable to use effective contraception for the duration of the study. * Regular use of NMDA (N-methyl-D-aspartate) antagonists (i.e., memantine, ketamine, etc.) * Regular use of antiplatelet medications (i.e., aspirin) * Any medical or psychiatric condition that could interfere with participation or pose safety concerns * Unwilling or unable to provide informed consent

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