Safety and Efficacy of Injectable Klotho Plasmid Gene Therapy in Humans

Part of paid clinical trials in Austin, Texas.

Sponsor
Minicircle
Study ID
NCT07216781
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
23 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Injectable Plasmid Klotho Gene Therapy — GENETIC
    Injection of plasmid-delivered Klotho gene therapy

Study Details

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 understand the cognitive and health benefits of the Klotho gene therapy.

Key Dates

Start date
Oct 6, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Schedule of Administration and Sample Selection
    This arm includes cognitive and health battery at multiple intervals pre- and post-administration of Klotho

Primary Outcome Measure

Concentration of Serum α-Klotho Measured by Enzyme-Linked Immunosorbent Assay (pg/mL) [ Time Frame: Measured 1 month before and 7 days before injection, then 3 days, 7 days, 1 month, 3 months, 6 months after ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Apeiron CenterAustinTexas78701
Mac Davis
[email protected]
512-630-0882

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By research site
Apeiron Center· Austin, TX

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