Klotho and follistatin gene therapy in healthy older adults
Evaluating the Safety and Efficacy of Injectable Combination Klotho and Follistatin Plasmid Gene Therapy in Humans -- An Interventional, Non-Placebo Controlled Pilot Phase Study
This trial will try a nonviral plasmid gene therapy delivering klotho and follistatin by subcutaneous injection to see if it is safe and improves cognitive and physical health in healthy adults aged 50 to 80.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Minicircle Industry-sponsored |
| Locations | 2 sites (Austin, Texas and 1 other locations) |
| Trial ID | NCT07285629 on ClinicalTrials.gov |
What this trial studies
Healthy volunteers aged 50–80 will undergo baseline cognitive and health testing, receive a subcutaneous injection of a nonviral plasmid carrying klotho and follistatin into abdominal fat, and then complete post-treatment cognitive and physiological assessments. The investigational product is administered at an off‑shore clinic, with only non‑treatment assessments (e.g., cognitive tests and blood draws) occurring at the U.S. site. Outcomes include safety measures and exploratory signals in physical function, cognitive performance, kidney markers, body composition, epigenetic age, and self‑reported well‑being. This is an early‑phase trial focused primarily on safety and preliminary efficacy signals in healthy adults.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 50–80 who can comply with visits, agree to contraception and pregnancy testing if applicable, are open to possible morphological changes, and are willing to travel to the off‑shore dosing clinic.
Not a fit: People with a history of cancer, autoimmune disease, chronic kidney or liver disease, those on immunosuppressive or regular antiplatelet or NMDA antagonist therapy, pregnant or breastfeeding individuals, or anyone unwilling to travel or provide informed consent are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the therapy could lead to improvements in physical and cognitive function, kidney health markers, body composition, biological aging markers, and overall well‑being in older adults.
How similar studies have performed: Preclinical animal studies of klotho and follistatin gene delivery have shown functional benefits, but human data are very limited and nonviral plasmid delivery in people remains largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Austin, Texas and 1 other locations
- Apeiron Center — Austin, Texas, United States (Recruiting)
- Global Alliance of Regenerative Medicine (GARM) Clinic — Roatán, Bay Islands, Honduras (Not_yet_recruiting)
Study contacts
- Study coordinator: Mac Davis
- Email: coordinator@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.