Safety and Efficacy of Klotho and Follistatin Gene Therapy
Evaluating the Safety and Efficacy of Injectable Combination Klotho and Follistatin Plasmid Gene Therapy in Humans -- An Interventional, Non-Placebo Controlled Pilot Phase Study
Minicircle
30 participants
Dec 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria9
- 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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Interventions
Injection of nonviral plasmid-delivered follistatin and klotho gene therapy
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07285629