aKLmRNA-mediated Protein Replacement Therapy

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Aging

In brief

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 facts

Study ID

NCT07544420

Run by

Klothea Bio Inc

People needed

21

Starts

2026-05-15

Expected to finish

2026-11-30

Last updated by the study team

2026-04-22

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subjects will be excluded from the trial if they present one or more of the following conditions:
• Known of suspected allergy to IMP or related procedure
• Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, if considered relevant by the Investigator
• Contraindications for the use of emergency treatments
• Clinically relevant findings at screening, e.g., active diseases of any kind particularly infections
• History of chronic alcohol or drug abuse/ dependence within the past 5 yearsUse of any prescription or over-the-counter medication within 7 days prior to first dosing or planned use during the study period, with the exception of medications considered medically necessary and administered at a stable dose and regimen. Stable medication is defined as medication for which no initiation, discontinuation, or dose adjustment has occurred for at least 3 monthsprior to first dosing and for which no change is anticipated during the study period. Occasional use of paracetamol (acetaminophen) and/or ibuprofen is permitted at the discretion of the investigator.
• Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub investigators, or study nurse) or employee of the Sponsor
• Known or suspected pregnancy, planned pregnancy of lactation
• Clinically significant unstable psychiatric illness in the past 6 months
• Presence of autoimmune disease, autoinflammatory syndrome, or immunological deficiency syndrome (including human immunodeficiency virus (HIV) infection)
• Relevant cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the Investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry
• Presence of end stage kidney failure (on dialysis)
• Current or anticipated use of immunosuppressive drugs such as, but not limited to, azathioprine, cyclosporine, methotrexate, tacrolimus, or mycophenylate within 2 months or any myelosuppressive or cytotoxic chemotherapies within the 12 months prior to the screening visit. Use of systemic corticosteroids equivalent to ≥20mg/week prednisone within the past 4 weeks before screening and during the course of the study (intranasal or inhaled steroids for allergies/asthma is allowed)
• History within the last 2 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment; or has a life expectancy of <2 years.
• Patients with long covid-19 showing long-term neurological sequelae within the past 12 months at the time of screening
• Has had a history within the last 5 years of a serious infectious disease affecting the brain, liver, lung and/or kidneys.
• Refractory epilepsy (has had seizures within the past 2 years)
• Hypothyroidism or vitamin B12 deficiency (patients with corrected hypothyroidism or vitamin B12 deficiency are eligible for the study provided that treatment has been stable for 3 months before study entry)
• Patient has hemochromatosis
• Pre-existing PEG antibodies of significant levels

Where it is running

• GARM — Roatán, Bay Islands, Honduras

Full record on ClinicalTrials.gov

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