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Phase 1RecruitingGeroscience intervention

Phase I Trial of a Single Administration of aKLmRNA-Mediated Protein Replacement Therapy (AKL003)

An Open-Label, Single-Arm Phase I Trial to Evaluate the Safety, Tolerability, and Serum Alpha-Klotho Protein Expression Following a Single Administration of Alpha Klotho mRNA (aKLmRNA), AKL003

Sponsor
Klothea Bio Inc (Industry)
Enrollment
20 planned
Conditions
Aging
Interventions
aKLmRNA (AKL003)
Ages
adults, older adults
Registry
NCT07544420

Full record on ClinicalTrials.gov

From the registry

This is an open-label, single-arm, single-site Phase I trial in a total of 20 healthy participants at GARM Próspera, Roatán, Honduras. Each participant receives one intravenous administration of 0.5 mg AKL003 on Day 0. Screening is followed by one treatment visit at GARM Próspera covering Day -1 to Day 2. Scheduled follow-up comprises Day 7 and the actual remote Final Visit (nominal Day 28 ±7 days), following local assessments under Investigator oversight. Safety is assessed through adverse events, clinical examinations, vital signs, ECG and laboratory testing. Six months of passive safety follow-up after the individual Final Visit or Early Termination Visit. PsyTool, QoL, Oura and DNA methylation assessments are retained. Exploratory changes do not establish clinical efficacy without a concurrent control group.

Primary outcomes

  • Overall incidence and severity of unsolicited AEs by treatment group
  • • Overall incidence and severity of solicited reactogenicity events by treatment group

History

  1. Study completion expected

  2. Primary completion expected

  3. Now recruiting

    , from Not yet recruiting to Recruiting

  4. Completion moved to Apr 30, 2027

    , from Nov 30, 2026 to Apr 30, 2027

  5. Last registry update

  6. Started

  7. Registered