Healthy ParticipantsPhase 1NCT06390098

Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of ASN51

A Phase 1 study testing ASN51 in people with Healthy Participants, run by Asceneuron S.A. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a phase 1, open-label, positron emission tomography (PET) study in healthy adult participants to determine the relationship between plasma concentration and brain target occupancy of ASN51 following a single oral dose. Read more about this study

Who is it for?: Ages 25 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: ASN51
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited Kingdom
Study dates: 9 Aug 2021to 12 Oct 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring. A participant with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the participant, (b) will not interfere with study procedures or confound study results, and (c) is not otherwise exclusionary
Men or women aged 25-55 years, inclusive (age range was selected on grounds of radiation burden).
Women of child-bearing potential (WOCBP) with partners of child-bearing potential must agree to use highly effective contraception from at least 28 days before first tracer dosing through 30 days after last dose of study medication. All WOCBP must have a negative pregnancy test result before administration of test article. Vasectomized partner is also an accepted a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.
WOCBP must be postmenopausal (the last menstrual period was at least 12 months ago, and follicle-stimulating hormone at screening confirms postmenopausal status, or have no uterus, ovaries, or fallopian tubes). Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
Non-sterilized male participants who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 1 day prior to the first tracer administration throughout the total duration of the treatment period and 90 days after the last dose of study drug. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male participants should refrain from sperm donation throughout this period.
Body weight > 50.0 kilograms (kg) for men and > 45.0 kg for women and Body Mass Index within the range 18.5-30.0 kilograms per square meter (kg/m^2) (inclusive).

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Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures.
Participants must be, in the opinion of the Investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
Participants must be fluent in the local language.
Participants must agree not to post any personal medical data related to the study or information related to the study on any website or social media site (e.g., Facebook, Twitter, etc.) until the trial has completed.

Who cannot join

A positive urine drug screen/alcohol test at Screening or Day -1.
Any history of psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation.
Significant suicide risk as assessed by the Columbia Suicide severity Rating Scale (C-SSRS)
A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at Screening.
A positive test for human immunodeficiency virus (HIV) antibody at Screening.

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Alanine aminotransferase or aspartate aminotransferase levels greater than 1.5 times the upper limit of normal (ULN) at Screening or between Screening and first dose of tracer.
Frequently used any tobacco-containing (e.g., cigar, cigarette, or snuff) or nicotine-containing product (e.g., nicotine chewing gum, nicotine plasters, or other product used for smoking cessation) within 3 months prior to first dose of tracer. Frequent use is defined as 3 or more days per week. Use of any tobacco- or nicotine-containing product is prohibited within 1 week of first dose of tracer.
History of regular alcohol consumption within 12 months of the study defined as an average weekly intake of >21 alcoholic units/week for men or >14 alcoholic units/week for women.
Regularly consumed (e.g., more days than not) excessive quantities of xanthine-containing beverages (e.g., more than five cups of coffee or the equivalent per day) within 30 days prior to Screening or between Screening and first dose of tracer.
Received or used an investigational product (including placebo) or device within the following time period prior to the first tracer dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Use of prescription or non-prescription drugs, vitamins, herbal, and dietary supplements (including St John's Wort) within 7 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study tracer medication, unless in the opinion of the Investigator and Medical Monitor, the medication will not interfere with the study procedures or compromise Participant safety.
History of clinically significant sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
Loss of more than 400 milliliters (mL) of blood within 3 months prior to first dose of tracer, i.e., blood donor.
A positive serum pregnancy test or lactation.
A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion. Participants with a history of cholecystectomy should be excluded.
A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic abnormality.
A clinically significant abnormality on physical examination, neurological examination, electrocardiogram (ECG), or laboratory evaluations at screen or between screen and first tracer dose administration.
A corrected QT(total time from ventricular depolarization to complete repolarization) interval measurement corrected according to the Fridericia rule (QTcF) > 450 milliseconds (msec) for males and 470 msec for females during controlled rest at screen or between screen and first tracer dose administration, or family history of long QT syndrome.
Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
PR (PQ) interval shortening < 120 msec (PR < 120 msec but > 110 msec is acceptable if there is no evidence of ventricular pre-excitation).
PR (PQ) interval prolongation (>220 msec), intermittent second- (Wenckebach block while asleep or in deep rest is not exclusionary) or third-degree AV block.
Persistent or intermittent complete bundle branch block (BBB), incomplete bundle branch block (IBBB), or intraventricular conduction delay (IVCD) with QRS > 120 msec.
A clinically significant vital signs abnormality at screening This includes, but is not limited to, 3 measurements (each 5 minutes apart) in the seated position: (a) systolic blood pressure < 90 or >140 millimeters of mercury (mmHg), (b) diastolic blood pressure <50 or > 95 mmHg, or (c) heart rate < 45 or >100 beats per minute. The average of the 3 measurements should be used to assess eligibility at screening.
Significant (> 10%) weight loss or gain within 30 days prior to Screening and first tracer dose administration.
A history of seizure. History of a single benign febrile convulsion of childhood is permitted.
A history of head trauma, including closed head injury with loss of consciousness.
A history of symptomatic orthostatic hypotension (i.e., postural syncope).
A history of neuroleptic malignant syndrome.
A history of chronic urinary tract infections.
The participant is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason.
Currently employed by Asceneuron SA or by a clinical trial site participating in this study, or a first-degree relative of an Asceneuron SA employee or of an employee at a participating clinical trial site.
Unsatisfactory venous access
Significant exposure to ionizing radiation as part of research within the previous 12 months prior to first tracer dose administration.
Unsuitable or unwilling to undergo the imaging procedures, as determined by an magnetic resonance imaging (MRI) safety questionnaire. Reasons for exclusion include but are not limited to presence of a cardiac pacemaker or other implanted electronic device; ferromagnetic metal foreign bodies, intracranial aneurysm clips or other metallic objects; non-MRI compatible heart valves; inner ear implants; or a history of claustrophobia.
Significant structural brain abnormality, as determined by MRI.
Contraindication for arterial cannulation: Allen's test indicating potential risk in placement of the arterial cannula.
Participants with a COVID-19 vaccination within two weeks of screening or due to receive second dose of COVID-19 vaccine while participating in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hammersmith
London

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Adult Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of ASN51 Following a Single Oral Dose

Conditions: Healthy Participants
Being tested: ASN51

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASN51Drug
Oral

Study groups in NCT06390098
Study group	Role	What they receive
ASN51	Experimental	Participants received low, medium, and high doses of ASN51, orally on Day 1 of imaging sessions 2 and 3 before the PET scan during the study. Receives: Drug: ASN51

What is being measured

The primary outcome is the main question the study is designed to answer.

Regional Total Volume of Distribution (VT) of [18F]-IMA601 in Frontal Lobe at Each Brain Scan
Regional VT of [18F]-IMA601 in frontal lobe at each brain scan was measured with a PET scan. Participants received an intravenous (IV) dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in Anterior Cingulate at Each Brain Scan
Regional VT of [18F]-IMA601 in anterior cingulate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in Caudate at Each Brain Scan
Regional VT of [18F]-IMA601 in the caudate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in Putamen at Each Brain Scan
Regional VT of [18F]-IMA601 in putamen at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in Accumbens at Each Brain Scan
Regional VT of [18F]-IMA601 in accumbens at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in Amygdala at Each Brain Scan
Regional VT of [18F]-IMA601 in amygdala at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in Cerebral White Matter at Each Brain Scan
Regional VT of [18F]-IMA601 in cerebral white matter at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Measured: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose

Secondary outcomes (9)

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAE is defined as an AE that emerges during treatment (having been absent before treatment) or that worsens after treatment. Serious TEAE is defined as an event that results in death, is considered life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent/significant disability/incapacity, results in a congenital anomaly/birth defect; or other medially important serious medical event.
Measured: Up to approximately 2.1 months
Number of Participants With Serious TEAEs up to 4 Weeks After Last Administration
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Serious TEAE is defined as an event that results in death, is considered life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent/significant disability/incapacity, results in a congenital anomaly/birth defect; or other medially important serious medical event.
Measured: Up to 4 weeks
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Laboratory tests including hematology, biochemistry, coagulation, serology, pregnancy and follicle stimulating hormone (FSH) test (only for females), and urinalysis were performed. Number of participants with clinically significant abnormalities in laboratory parameters were reported. Clinical significance was determined by the investigator.
Measured: Up to approximately 2.1 months
Number of Participants With Clinically Significant Changes in Vital Signs
Vital signs including seated systolic blood pressure, seated diastolic blood pressure, seated heart rate, respiratory rate, and tympanic temperature were assessed. Number of participants with clinically significant changes in vital signs were reported. Clinical significance was determined by the investigator.
Measured: Up to approximately 2.1 months
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
ECG parameters including Ventricular rate, QRS complex of the ECG reflects the rapid depolarization of the right and left ventricles (QRS) interval, portion of the ECG between consecutive R waves, representing the ventricular rate (PR) interval, and QTc interval with Fridericia's correction method (QTcF) and QTc interval with Bazett's correction method (QTcB) were measured. Number of participants with clinically significant abnormal ECG findings were reported. Clinical significance was determined by the investigator.
Measured: Up to approximately 2.1 months
Number of Participants With Clinically Significant Abnormal Physical Examinations
Complete physical examination including general appearance; head, eyes, ears, nose, and throat; and cardiovascular, dermatologic, respiratory, gastrointestinal, musculoskeletal, and neurologic systems were performed. Number of participants with clinically significant abnormal physical examinations were reported. Clinical significance was determined by the investigator.
Measured: Up to approximately 2.1 months
Plasma Concentration of ASN51 at Each Post-dose PET Scan
Measured: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 and 72 hours post-dose on Day 4
Estimated O-GlcNAcase Receptor Occupancy (RO) by Plasma Concentration of ASN51 and PET Scan
Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to the start of each post-dose PET scan. Participant wise data was reported for this outcome measure.
Row titles include participant number, PET scan session, post-dose time, and plasma concentration.
Measured: At 6 hours post-dose on Day 1 (for participant 1) and 31 hours post-dose on Day 1 (for participants 2 and 3), and at 48 hours post-dose on Day 1 (all participants)
Receptor Occupancy as Assessed by Plasma Concentration That Corresponds to 50% Occupancy (EC50)
Occupancy estimates were plotted against plasma concentrations of ASN51, corresponding to post-dose PET scan. The following model was fitted to occupancy data set: Occ=100*Cp/Cp+EC50. Where Occ was the target occupancy (%), Cp was measured plasma concentration of ASN51 (ng/ml) and EC50 was the plasma concentration of ASN51 that corresponds to 50% occupancy. The relationship between exposure and occupancy was explored by direct fitting of a saturation model to pooled (across participants and scans) VT data, to obtain an estimate of EC50 for occupancy by ASN51.
Measured: At 6, 31 and at 48 hours post-dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Aug 202112 Oct 2021

First posted30 Apr 2024
Study start9 Aug 2021
Primary completion12 Oct 2021
Study completion12 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies 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: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06390098
Sponsor's protocol ID: ASN51-102
Status last verified: May 2025
First submitted: 23 Apr 2024
Last updated: 8 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Not expected to be made available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Positron Emission Tomography Study in Healthy Adult Subjects to Determine the Relationship Between Plasma Concentration and Brain Target Occupancy of ASN51 Following a Single Oral Dose
ClinicalTrials.gov ID: NCT06390098
Acronym / sponsor ID: ASN51-102
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 3 participants (actual)
Lead sponsor: Asceneuron S.A.Industry (pharma, biotech, devices)
Collaborators: Hammersmith Medicines Research Invicro
Study start: 9 Aug 2021 (actual)
Primary completion: 12 Oct 2021 (actual)
Study completion: 12 Oct 2021 (actual)
First posted: 30 Apr 2024 (actual)
Results: Posted 8 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ASN51	Experimental	Drug: ASN51Participants received low, medium, and high doses of ASN51, orally on Day 1 of imaging sessions 2 and 3 before the PET scan during the study.

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy as determined by the Investigator, based on a medical evaluation including medical history physical examination, neurological examination, laboratory tests and cardiac monitoring. A participant with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the participant, (b) will not interfere with study procedures or confound study results, and (c) is not otherwise exclusionary
Men or women aged 25-55 years, inclusive (age range was selected on grounds of radiation burden).
Women of child-bearing potential (WOCBP) with partners of child-bearing potential must agree to use highly effective contraception from at least 28 days before first tracer dosing through 30 days after last dose of study medication. All WOCBP must have a negative pregnancy test result before administration of test article. Vasectomized partner is also an accepted a highly effective birth control method provided that partner is the sole sexual partner of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the surgical success.
WOCBP must be postmenopausal (the last menstrual period was at least 12 months ago, and follicle-stimulating hormone at screening confirms postmenopausal status, or have no uterus, ovaries, or fallopian tubes). Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
Non-sterilized male participants who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom plus spermicide from 1 day prior to the first tracer administration throughout the total duration of the treatment period and 90 days after the last dose of study drug. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male participants should refrain from sperm donation throughout this period.

Key exclusion criteria (38 listed)

A positive urine drug screen/alcohol test at Screening or Day -1.
Any history of psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
A diagnosis of intellectual disability (intellectual developmental disorder) or mental retardation.
Significant suicide risk as assessed by the Columbia Suicide severity Rating Scale (C-SSRS)
A positive Hepatitis B surface antigen or positive Hepatitis C antibody result at Screening.

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
ASN51Oral	Drug	ASN51

Primary outcome

Regional Total Volume of Distribution (VT) of [18F]-IMA601 in Frontal Lobe at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in frontal lobe at each brain scan was measured with a PET scan. Participants received an intravenous (IV) dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Regional VT of [18F]-IMA601 in Anterior Cingulate at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in anterior cingulate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Regional VT of [18F]-IMA601 in Caudate at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in the caudate at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Regional VT of [18F]-IMA601 in Putamen at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in putamen at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Regional VT of [18F]-IMA601 in Accumbens at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in accumbens at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Regional VT of [18F]-IMA601 in Amygdala at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in amygdala at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.
Regional VT of [18F]-IMA601 in Cerebral White Matter at Each Brain Scan
Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose
Regional VT of [18F]-IMA601 in cerebral white matter at each brain scan was measured with a PET scan. Participants received an IV dose of the radiolabelled tracer, [18F]-IMA601, at the start of each PET scan. Participant wise data was reported for this outcome measure.

9 secondary outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to approximately 2.1 months
Number of Participants With Serious TEAEs up to 4 Weeks After Last Administration
Time frame: Up to 4 weeks
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Up to approximately 2.1 months
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: Up to approximately 2.1 months
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Time frame: Up to approximately 2.1 months
Number of Participants With Clinically Significant Abnormal Physical Examinations
Time frame: Up to approximately 2.1 months
Plasma Concentration of ASN51 at Each Post-dose PET Scan
Time frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 16 hours post-dose on Day 1; 24 and 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 and 72 hours post-dose on Day 4
Estimated O-GlcNAcase Receptor Occupancy (RO) by Plasma Concentration of ASN51 and PET Scan
Time frame: At 6 hours post-dose on Day 1 (for participant 1) and 31 hours post-dose on Day 1 (for participants 2 and 3), and at 48 hours post-dose on Day 1 (all participants)
Receptor Occupancy as Assessed by Plasma Concentration That Corresponds to 50% Occupancy (EC50)
Time frame: At 6, 31 and at 48 hours post-dose on Day 1

Results and safety

Results posted to the registry on 8 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ASN51	3	3

Primary outcome: Regional Total Volume of Distribution (VT) of [18F]-IMA601 in Frontal Lobe at Each Brain Scan

Time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose. Number. Unit: milliliters/cubic centimeter (mL/cm^3)

Measure	All Participants n = 3	ASN51 Low Dose n = 3	ASN51 Medium Dose n = 1	ASN51 High Dose n = 1
Participant 1, PET Scan 1, Baseline	14.09	–	–	–
Participant 1, PET Scan 2, 6 hours post-dose, Day 1	–	–	–	1.82
Participant 1, PET Scan 3, 48 hours post-dose, Day 1	–	4.76	–	–
Participant 2, PET Scan 1, Baseline	16.08	–	–	–
Participant 2, PET Scan 2, 31 hours post-dose, Day 1	–	3.90	–	–
Participant 2, PET Scan 3, 48 hours post-dose, Day 1	–	4.55	–	–
Participant 3, PET Scan 1, Baseline	16.38	–	–	–
Participant 3, PET Scan 2, 31 hours post-dose, Day 1	–	–	3.86	–

Population analysed: PET population included all participants who received study medication, had a baseline PET scan, at least one post-baseline PET scan, and a pharmacokinetic (PK) result immediately preceding PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.

Primary outcome: Regional VT of [18F]-IMA601 in Anterior Cingulate at Each Brain Scan

Measure	All Participants n = 3	ASN51 Low Dose n = 3	ASN51 Medium Dose n = 1	ASN51 High Dose n = 1
Participant 1, PET Scan 1, Baseline	16.35	–	–	–
Participant 1, PET Scan 2, 6 hours post-dose, Day 1	–	–	–	1.85
Participant 1, PET Scan 3, 48 hours post-dose	–	5.41	–	–
Participant 2, PET Scan 1, Baseline	19.34	–	–	–
Participant 2, PET Scan 2, 31 hours post-dose, Day 1	–	4.28	–	–
Participant 2, PET Scan 3, 48 hours post-dose, Day 1	–	5.13	–	–
Participant 3, PET Scan 1, Baseline	19.89	–	–	–
Participant 3, PET Scan 2, 31 hours post-dose, Day 1	–	–	4.21	–

Population analysed: PET population included all participants who received study medication, had a baseline PET scan, at least one post-baseline PET scan, and a PK result immediately preceding PET scan. Here, "number analyzed" signifies specific participant evaluated in respective arm at a specified timepoint.

Primary outcome: Regional VT of [18F]-IMA601 in Caudate at Each Brain Scan

Measure	All Participants n = 3	ASN51 Low Dose n = 3	ASN51 Medium Dose n = 1	ASN51 High Dose n = 1
Participant 1, PET Scan 1, Baseline	10.20	–	–	–
Participant 1, PET Scan 2, 6 hours post-dose, Day 1	–	–	–	1.23
Participant 1, PET Scan 3, 48 hours post-dose, Day 1	–	3.21	–	–
Participant 2, PET Scan 1, Baseline	13.74	–	–	–
Participant 2, PET Scan 2, 31 hours post-dose, Day 1	–	3.19	–	–
Participant 2, PET Scan 3, 48 hours post-dose, Day 1	–	3.89	–	–
Participant 3, PET Scan 1, Baseline	14.70	–	–	–
Participant 3, PET Scan 2, 31 hours post-dose, Day 1	–	–	3.31	–

Primary outcome: Regional VT of [18F]-IMA601 in Putamen at Each Brain Scan

Measure	All Participants n = 3	ASN51 Low Dose n = 3	ASN51 Medium Dose n = 1	ASN51 High Dose n = 1
Participant 1, PET Scan 1, Baseline	15.38	–	–	–
Participant 1, PET Scan 2, 6 hours post-dose, Day 1	–	–	–	1.98
Participant 1, PET Scan 3, 48 hours post-dose, Day 1	–	5.41	–	–
Participant 2, PET Scan 1, Baseline	19.07	–	–	–
Participant 2, PET Scan 2, 31 hours post-dose, Day 1	–	4.37	–	–
Participant 2, PET Scan 3, 48 hours post-dose, Day 1	–	5.22	–	–
Participant 3, PET Scan 1, Baseline	19.32	–	–	–
Participant 3, PET Scan 2, 31 hours post-dose, Day 1	–	–	4.39	–

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 2.1 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
ASN51 Low Dose	0 of 3 (0%)	0 of 3 (0%)	0 of 3
ASN51 Medium Dose	0 of 1 (0%)	1 of 1 (100%)	0 of 1
ASN51 High Dose	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Not expected to be made available

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 ASN51 in people with Healthy Participants, run by Asceneuron S.A. at 1 site in United Kingdom.

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 10 inclusion and 38 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: finished, as of the sponsor's last update on 8 May 2025. 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 United Kingdom. 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. 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?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Regional Total Volume of Distribution (VT) of [18F]-IMA601 in Frontal Lobe at Each Brain Scan (time frame: PET Scan 1 (Baseline), PET Scan 2 (6 hours post-dose [for participant 1] and 31 hours post-dose for [participants 2 and 3] on Day 1), PET Scan 3 (48 hours post-dose on Day 1) after final ASN51 dose). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390098.

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 8 May 2025.