Safety and Efficacy of Klotho and Follistatin Gene Therapy

Plain-language summary

This study examines the safety and efficacy of a gene therapy involving the follistatin and klotho genes. It enrolls generally healthy adults between 50 and 80 years of age. The study is in Early Phase 1 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Early Phase 1

Status

Recruiting

Sponsor

Minicircle

Intervention

Follistatin and klotho gene therapy

Start date

12/16/2025

Estimated completion

6/1/2026

Countries

United States, Honduras

Related genes

Locations

• Austin, United States
• Roatán, Honduras

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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