aKLmRNA-mediated Protein Replacement Therapy

ConditionAging

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age50-75

SponsorKlothea Bio Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Written informed consent (ICF) signed and dated by the patient

Ability and willingness to co-operate with the investigator and to comply with the requirements of the entire study.

Healthy subjects, 25 50 to 75 90 years of age

Sexually active females of childbearing potential and male partners of sexually active females of childbearing potential must use medically accepted form of contraception or be surgically sterile (hysterectomy or bilateral oophorectomy).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

aKLmRNA (AKL003)
Drug
Each subject will be treated every 4 weeks for a total of 2 times with aKLmRNA via i.v.
Placebo
Other intervention
Each subject will be treated every 4 weeks for a total of 2 times with TRIS buffer

Treatment groups

21 Participants

are divided into 2 treatment groups

Group A: aKLmRNA (AKL003)Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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)

Secondary outcomes

• 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

Other outcomes

• 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Klothea Bio Inc

Lead sponsor

Source ClinicalTrials.gov

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