Status:
RECRUITING
Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans
Lead Sponsor:
Minicircle
Conditions:
Healthy Adults
Eligibility:
All Genders
23-90 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety and efficacy of a gene therapy for Klotho, delivered via a nonviral plasmid in healthy adult volunteers. Additionally, this study seeks to unders...
Detailed Description
Note that the investigational product will be administered at a site outside of the U.S. which is not under FDA jurisdiction, and only non-treatment pre/post outcome assessments (e.g., cognitive asses...
Eligibility Criteria
Inclusion
- 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
- Women of childbearing potential who are unwilling or unable to use effective contraception for the duration of the study
- History of cancer diagnosis
- Preexisting medical issues that may be exacerbated by the treatment
- Has received any gene therapy within the past 12 months
- Unwilling or unable to provide written informed consent
Key Trial Info
Start Date :
October 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07216781
Start Date
October 6 2025
End Date
August 1 2026
Last Update
October 15 2025
Active Locations (2)
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1
Apeiron Center
Austin, Texas, United States, 78701
2
GARM Clinic
Roatán, Bay Islands, Honduras