Injectable nonviral Klotho plasmid gene therapy for healthy adults
Evaluating the Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans: An Interventional, Non-Placebo-Controlled Pilot Phase Study
This will test whether a single subcutaneous injection of a nonviral Klotho plasmid is safe and can improve thinking and overall health in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 23 Years to 90 Years |
| Sex | All |
| Sponsor | Minicircle Industry-sponsored |
| Locations | 2 sites (Austin, Texas and 1 other locations) |
| Trial ID | NCT07216781 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional protocol gives a nonviral plasmid encoding the Klotho gene by subcutaneous injection into abdominal fat in healthy adult volunteers, with dosing administered at an overseas clinic. Participants complete baseline and multiple post-injection assessments including blood draws, health screenings, cognitive testing, questionnaires, and brain perfusion/function measures. The U.S. site performs only non-treatment pre- and post-procedure outcome assessments while the investigational administration occurs outside FDA jurisdiction. The primary aim is to characterize safety and tolerability, with exploratory measures of cognitive and systemic health effects.
Who should consider this trial
Good fit: Healthy adults willing to give informed consent, comply with contraception and pregnancy-testing requirements if applicable, travel for the injection outside the U.S., and complete repeated blood draws and cognitive testing are ideal candidates.
Not a fit: People with a history of cancer, significant preexisting medical conditions, recent gene therapy within 12 months, or women unwilling to use effective contraception are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the therapy could help preserve or improve cognitive function and aspects of physical health that contribute to a longer healthspan.
How similar studies have performed: Animal studies of Klotho gene delivery have shown cognitive and health benefits, but nonviral plasmid Klotho delivery in humans is novel and has very limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: * 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
Where this trial is running
Austin, Texas and 1 other locations
- Apeiron Center — Austin, Texas, United States (Recruiting)
- GARM Clinic — Roatán, Bay Islands, Honduras (Not_yet_recruiting)
Study contacts
- Study coordinator: Mac Davis
- Email: mac@minicircle.io
- Phone: 512-630-0882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.