AgingPhase 1NCT07544420
aKLmRNA-mediated Protein Replacement Therapy
A Phase 1 study testing aKLmRNA (AKL003) in people with Aging, run by Klothea Bio Inc at 1 site in Honduras.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- aKLmRNA (AKL003)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteHonduras
- Study dates
- 15 May 2026to 30 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site
GARM
Roatán, Bay Islands, 34101
Heather Terry, (504) 2408-3544, heather@garmclinic.com
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (Protein Expression) of Multiple Administrations of Alpha Klotho mRNA (aKLmRNA), aKL003
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.
Read the detailed description
Systemic reactogenicity events, such as fever, headache, myalgia, fatigue, nausea/vomiting, diarrhea, and increased heart rate, will be assessed as adverse events using the WHO grading scale.
All subjects will be informed about potential clinical activity and reactogenicity, which may be influenced by increased aKL serum levels or the lipid nanoparticle formulation. Participants will be instructed to contact the study site to schedule an on-site visit in case of any unexpected adverse event (unscheduled visit, see Schedule of Activities table). All such occurrences will be documented as part of the drug candidate's safety evaluation.
Subjects will provide self-reported data on clinical activity, duration, and effects via a digital diary and in-person assessments during scheduled clinic visits. Additionally, they will be provided with an electronic memory aid for daily symptom tracking throughout the study. Participants will also complete a Quality-of-Life Impact Questionnaire (QOLIQ) at baseline and weekly throughout the study. Furthermore, continuous monitoring of heart rate, heart rate variability, and sleep quality will be conducted using a minimally invasive Oura ring.
Participants randomized to placebo who successfully complete the randomized Phase I study may be offered participation in an optional open-label extension to receive Klotho. The purpose of the open-label extension is to provide access to the investigational product and to collect additional safety and pharmacokinetic data. Participation in the open-label extension is voluntary and subject to predefined eligibility criteria and safety review. Data from the open-label extension will be analyzed separately and will not contribute to the primary analysis of the randomized Phase I study.
Participants randomized to placebo in the randomized Phase I study will not receive investigational product during the blinded treatment period. In order to provide eligible participants access to Klotho after completion of the randomized study phase and to collect additional safety and pharmacokinetic data, an optional open-label extension (OLE) is planned.
The open-label extension is not intended to evaluate efficacy and is not part of the primary analysis of the randomized Phase I study.
- Conditions
- Aging
- Being tested
- aKLmRNA (AKL003), Placebo
- Keywords
- Longevity, Healthy Aging, Klotho, mRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aKLmRNA (AKL003)Drug
Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA via i.v.
PlaceboOther
Each subject will be treated every 4 weeks for a total of 2 times with TRIS buffer
| Study group | Role | What they receive |
|---|---|---|
| aKLmRNA (AKL003) | Experimental | Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA (AKL003) Receives: Drug: aKLmRNA (AKL003) |
| Placebo | Placebo comparator | Each subject will be treated every 4 weeks for a total of 2 times with TRIS-Buffer Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence and severity of unsolicited AEs by treatment group
- To characterize the overall safety and tolerability of multiple administrations of the Investigational Medicinal product (IMP), aKLmRNA (AKL003), in healthy volunteers
Measured: From first dose through end of study (Day 60)
• Overall incidence and severity of solicited reactogenicity events by treatment group
- To characterize the overall safety and tolerability of multiple administrations of the Investigational Medicinal product (IMP), aKLmRNA (AKL003), in healthy volunteers
Measured: From first dose through end of study (Day 60)
Secondary outcomes (2)
• Increase in serum aKL levels over the mean of the baseline values until end of study
- To characterize the serum levels of aKL protein as a function of the dose applied and time post administration.
Measured: Baseline through Day 60
• aKL serum level by treatment group
- To characterize the serum levels of aKL protein as a function of the dose applied and time post administration.
Measured: Baseline through Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klothea Bio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas A Tucker, MD, Principal investigator, GARM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544420
- Sponsor's protocol ID
- AKL003
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (Protein Expression) of Multiple Administrations of Alpha Klotho mRNA (aKLmRNA), aKL003
- ClinicalTrials.gov ID
- NCT07544420
- Acronym / sponsor ID
- AKL003
- Conditions
- Aging
- Keywords
- Longevity, Healthy Aging, Klotho, mRNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Klothea Bio IncIndustry (pharma, biotech, devices)
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Systemic reactogenicity events, such as fever, headache, myalgia, fatigue, nausea/vomiting, diarrhea, and increased heart rate, will be assessed as adverse events using the WHO grading scale.
All subjects will be informed about potential clinical activity and reactogenicity, which may be influenced by increased aKL serum levels or the lipid nanoparticle formulation. Participants will be instructed to contact the study site to schedule an on-site visit in case of any unexpected adverse event (unscheduled visit, see Schedule of Activities table). All such occurrences will be documented as part of the drug candidate's safety evaluation.
Subjects will provide self-reported data on clinical activity, duration, and effects via a digital diary and in-person assessments during scheduled clinic visits. Additionally, they will be provided with an electronic memory aid for daily symptom tracking throughout the study. Participants will also complete a Quality-of-Life Impact Questionnaire (QOLIQ) at baseline and weekly throughout the study. Furthermore, continuous monitoring of heart rate, heart rate variability, and sleep quality will be conducted using a minimally invasive Oura ring.
Participants randomized to placebo who successfully complete the randomized Phase I study may be offered participation in an optional open-label extension to receive Klotho. The purpose of the open-label extension is to provide access to the investigational product and to collect additional safety and pharmacokinetic data. Participation in the open-label extension is voluntary and subject to predefined eligibility criteria and safety review. Data from the open-label extension will be analyzed separately and will not contribute to the primary analysis of the randomized Phase I study.
Participants randomized to placebo in the randomized Phase I study will not receive investigational product during the blinded treatment period. In order to provide eligible participants access to Klotho after completion of the randomized study phase and to collect additional safety and pharmacokinetic data, an optional open-label extension (OLE) is planned.
The open-label extension is not intended to evaluate efficacy and is not part of the primary analysis of the randomized Phase I study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aKLmRNA (AKL003) | Experimental | Drug: aKLmRNA (AKL003)Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA (AKL003) |
| Placebo | Placebo comparator | Other: PlaceboEach subject will be treated every 4 weeks for a total of 2 times with TRIS-Buffer |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aKLmRNA (AKL003)Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA via i.v. | Drug | aKLmRNA (AKL003) |
| PlaceboEach subject will be treated every 4 weeks for a total of 2 times with TRIS buffer | Other | Placebo |
Primary outcome
Overall incidence and severity of unsolicited AEs by treatment group
Time frame: From first dose through end of study (Day 60)
• To characterize the overall safety and tolerability of multiple administrations of the Investigational Medicinal product (IMP), aKLmRNA (AKL003), in healthy volunteers
• Overall incidence and severity of solicited reactogenicity events by treatment group
Time frame: From first dose through end of study (Day 60)
• To characterize the overall safety and tolerability of multiple administrations of the Investigational Medicinal product (IMP), aKLmRNA (AKL003), in healthy volunteers
2 secondary outcomes
• Increase in serum aKL levels over the mean of the baseline values until end of study
Time frame: Baseline through Day 60
• aKL serum level by treatment group
Time frame: Baseline through Day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Douglas A Tucker, MD principal investigator
GARM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing aKLmRNA (AKL003) in people with Aging, run by Klothea Bio Inc at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agustin Fernandez III (786-542-5499, AFS@advantagetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence and severity of unsolicited AEs by treatment group (time frame: From first dose through end of study (Day 60)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.