aKLmRNA-mediated Protein Replacement Therapy

Sponsor
Klothea Bio Inc
Study ID
NCT07544420
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • aKLmRNA (AKL003) — DRUG
    Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA via i.v.
  • Placebo — OTHER
    Each subject will be treated every 4 weeks for a total of 2 times with TRIS buffer

Study Details

This is a Phase 1b randomized, double-blind, placebo-controlled study to assess the safety and tolerability of a proprietary aKLmRNA formulated in lipid nanoparticles. Approximately 21 subjects will be enrolled. Each subject will receive a total of two injections during the study. The cohort will consist of approximately 21 subjects, with each receiving 0.5 mg aKLmRNA (AKL003) or placebo. Subjects will be randomized in a 2:1 ratio (active treatment:placebo). The placebo will be saline, matching the active treatment in both appearance and volume.

Key Dates

First listed
Apr 22, 2026
Start date
May 15, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
21 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: aKLmRNA (AKL003)
    Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA (AKL003)
  • Placebo Comparator: Placebo
    Each subject will be treated every 4 weeks for a total of 2 times with TRIS-Buffer

Primary Outcome Measure

Overall incidence and severity of unsolicited AEs by treatment group [ Time Frame: From first dose through end of study (Day 60) ]

Central Contacts

Related Studies