A Phase 1 interventional study of ASN51 in Healthy Participants, sponsored by Asceneuron S.A.. Completed at 1 site in United Kingdom. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Asceneuron S.A. · Phase 1, Interventional, and Treatment
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.
Asceneuron S.A. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: ASN51
Oral
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.
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
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.
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 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.
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
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.
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
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.
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
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.
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
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.
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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)
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.
Time frame: At 6, 31 and at 48 hours post-dose on Day 1
Participants took part in the study at an investigative site in United Kingdom from 09 August 2021 to 12 October 2021.
| Milestone | ASN51 |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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.
| milliliters/cubic centimeter (mL/cm^3) | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| 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 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 5.78 | — | — |
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.
| mL/cm^3 | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| 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 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 6.70 | — | — |
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.
| mL/cm^3 | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| 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 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 4.86 | — | — |
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.
| mL/cm^3 | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| 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 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 6.57 | — | — |
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.
| mL/cm^3 | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Participant 1, PET Scan 1, Baseline | 15.82 | — | — | — |
| Participant 1, PET Scan 2, 6 hours post-dose, Day 1 | — | — | — | 1.69 |
| Participant 1, PET Scan 3, 48 hours post-dose, Day 1 | — | 5.43 | — | — |
| Participant 2, PET Scan 1, Baseline | 21.14 | — | — | — |
| Participant 2, PET Scan 2, 31 hours post-dose, Day 1 | — | 4.42 | — | — |
| Participant 2, PET Scan 3, 48 hours post-dose, Day 1 | — | 5.36 | — | — |
| Participant 3, PET Scan 1, Baseline | 21.80 | — | — | — |
| Participant 3, PET Scan 2, 31 hours post-dose, Day 1 | — | — | 4.28 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 6.71 | — | — |
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.
| mL/cm^3 | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Participant 1, PET Scan 1, Baseline | 16.40 | — | — | — |
| Participant 1, PET Scan 2, 6 hours post-dose, Day 1 | — | — | — | 1.90 |
| Participant 1, PET Scan 3, 48 hours post-dose, Day 1 | — | 6.36 | — | — |
| Participant 2, PET Scan 1, Baseline | 22.30 | — | — | — |
| Participant 2, PET Scan 2, 31 hours post-dose, Day 1 | — | 4.76 | — | — |
| Participant 2, PET Scan 3, 48 hours post-dose, Day 1 | — | 6.00 | — | — |
| Participant 3, PET Scan 1, Baseline | 22.18 | — | — | — |
| Participant 3, PET Scan 2, 31 hours post-dose, Day 1 | — | — | 4.49 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 7.26 | — | — |
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.
| mL/cm^3 | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Participant 1, PET Scan 1, Baseline | 10.87 | — | — | — |
| Participant 1, PET Scan 2, 6 hours post-dose, Day 1 | — | — | — | 1.72 |
| Participant 1, PET Scan 3, 48 hours post-dose, Day 1 | — | 3.86 | — | — |
| Participant 2, PET Scan 1, Baseline | 12.72 | — | — | — |
| Participant 2, PET Scan 2, 31 hours post-dose, Day 1 | — | 3.32 | — | — |
| Participant 2, PET Scan 3, 48 hours post-dose | — | 3.80 | — | — |
| Participant 3, PET Scan 1, Baseline | 13.49 | — | — | — |
| Participant 3, PET Scan 2, 31 hours post-dose, Day 1 | — | — | 3.58 | — |
| Participant 3, PET Scan 3, 48 hours post-dose, Day 1 | — | 4.97 | — | — |
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.
| Participants | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Participants with TEAEs | 2 | 0 | 1 | 0 |
| Participants with Serious TEAEs | 0 | 0 | 0 | 0 |
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.
| Participants | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Number of Participants With Serious TEAEs up to 4 Weeks After Last Administration | 0 | 0 | 0 | 0 |
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.
| Participants | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | 0 | 0 | 0 | 0 |
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.
| Participants | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs | 0 | 0 | 0 | 0 |
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.
| Participants | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings | 0 | 0 | 0 | 0 |
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.
| Participants | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Abnormal Physical Examinations | 0 | 0 | 0 | 0 |
| nanograms/milliliter (ng/mL) | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|
| Day 1: 0.5 hour post-dose | 37.0 ± 8.78 | 192.0 | 43.5 |
| Day 1: 1 hour post-dose | 93.0 ± 6.16 | 181.0 | 189.0 |
| Day 1: 1.5 hours post-dose | 90.0 ± 7.79 | 159.0 | 293.0 |
| Day 1: 2 hours post-dose | 87.1 ± 11.98 | 144.0 | 283.0 |
| Day 1: 3 hours post-dose | 83.6 ± 8.92 | 142.0 | 245.0 |
| Day 1: 4 hours post-dose | 80.5 ± 17.12 | 134.0 | 253.0 |
| Day 1: 6 hours post-dose | 66.2 ± 7.77 | 121.0 | 199.0 |
| Day 1: 8 hours post-dose | 66.9 ± 11.22 | 115.0 | 201.0 |
| Day 1: 12 hours post-dose | 59.9 ± 9.73 | 103.0 | 153.0 |
| Day 1: 16 hours post-dose | 45.0 ± 6.74 | 96.9 | 153.0 |
| Day 2: 24 hours post-dose | 45.5 ± 6.24 | 81.7 | 133.0 |
| Day 2: 36 hours post-dose | 34.1 ± 4.71 | 58.2 | 95.3 |
| Day 3: 48 hours post-dose | 30.4 ± 3.37 | 46.3 | 88.2 |
| Day 4: 72 hours post-dose | 20.5 ± 1.28 | 28.9 | 54.8 |
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.
| percentage of receptor occupancy | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|
| Participant 1: PET Scan 2, 6 hours at 199.0 ng/mL | — | — | 92.2 |
| Participant 1: PET Scan 3, 48 hours at 30.3 ng/mL | 68.2 | — | — |
| Participant 2: PET Scan 2, 31 hours at 42.2 ng/mL | 84.5 | — | — |
| Participant 2: PET Scan 3, 48 hours at 29.4 ng/mL | 79.4 | — | — |
| Participant 3: PET Scan 2, 31 hours at 65.8 ng/mL | — | 89.7 | — |
| Participant 3: PET Scan 3, 48 hours at 26.7 ng/mL | 75.9 | — | — |
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.
| ng/mL | All Participants |
|---|---|
| Receptor Occupancy as Assessed by Plasma Concentration That Corresponds to 50% Occupancy (EC50) | 9.4 (6.4 to 12.3) |
Collected over Up to approximately 2.1 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| ASN51 Low Dose | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| ASN51 Medium Dose | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| ASN51 High Dose | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | All Participants | ASN51 Low Dose | ASN51 Medium Dose | ASN51 High Dose |
|---|---|---|---|---|
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/3 | 0/3 | 1/1 | 0/1 |
| Catheter site related reactionGeneral disorders | 2/3 | 0/3 | 0/1 | 0/1 |
| DysgeusiaNervous system disorders | 1/3 | 0/3 | 0/1 | 0/1 |
All treated set included all participants who received at least one dose of study drug.
| Age, Continuous(years) | ASN51 |
|---|---|
| Mean | 49.3 ± 4.93 |
| Sex: Female, Male(Participants) | ASN51 |
|---|---|
| Female | 2 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | ASN51 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | ASN51 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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Plan to share: No — Not expected to be made available
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Asceneuron S.A.