A Phase 1 interventional study of aKLmRNA (AKL003) and Placebo in Aging, sponsored by Klothea Bio Inc. Not yet recruiting at 1 site in Honduras. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Klothea Bio Inc · Phase 1, Interventional, and Prevention
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.
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.
This is the only study on the registry with Klothea Bio Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects will only be included in the trial if they meet all following criteria:
Exclusion Criteria:
Subjects will be excluded from the trial if they present one or more of the following conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA (AKL003)
Drug: aKLmRNA (AKL003)
Each subject will be treated every 4 weeks for a total of 2 times with TRIS-Buffer
Other: Placebo
Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA via i.v.
Each subject will be treated every 4 weeks for a total of 2 times with TRIS buffer
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
Time frame: 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
Time frame: From first dose through end of study (Day 60)
• 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.
Time frame: 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.
Time frame: Baseline through Day 60
• Change from baseline to day 60 in episodic memory performance measrued by Face-Name Associative Memory Exam
• To characterize the clinical activity after multiple administrations of aKLmRNA AKL003
Time frame: Baseline through Day 60
• Change from baseline to day 60 in attention and inhibitory control measured Flanker Test
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, including cognitive function
Time frame: Baseline through Day 60
• Change from baseline to day 60 in working memory performance measured by NIH Toolbox List Sorting Working Memory Test
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, including cognitive function
Time frame: Baseline through Day 60
• Change from baseline to day 60 in processing speed assessed by Oral Symbol Digit Test
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, including cognitive function
Time frame: Baseline through Day 60
• Change from baseline to day 60 in reaction time using digital repeated measures
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, including cognitive function,
Time frame: Baseline through Day 60
• Change from baseline in selected standardized neuropsychological assessments aligned with established cognitive testing platforms (CANTAB-based measures)
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, including cognitive function,
Time frame: Baseline through Day 60
• Change from baseline to day 60 in grip strength measured by a hand dynamometer
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, physical (muscle) function
Time frame: Baseline through Day 60
• Change from baseline to day 60 in functional exercise capacity assessed by6 -minute walk test
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, physical (muscle) function
Time frame: Baseline through Day 60
• Change from baseline to day 60 in lower body functional performance assessed by chair-rise or comparable assessment
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, physical (muscle) function
Time frame: Baseline through Day 60
• Change from baseline to day 60 in NAD+ levels measured in serum
• To explore the effects of aKLmRNA administration on functional and biological domains relevant to aging and healthspan, i immune/inflammatory function
Time frame: Baseline through Day 60
Change from baseline in telomere length (T/S ratio) in peripheral blood mononuclear cells (PBMCs), as measured by quantitative PCR (qPCR), at Day 60
Time frame: Baseline through Day 60
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Nov 2026, 6 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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