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

NCT06390098 | Completed Phase 1 Results

• 1 other identifier: ASN51-102
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  Up to approximately 2.1 months

• Number of Participants With Serious TEAEs up to 4 Weeks After Last Administration

  Up to 4 weeks

• Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

  Up to approximately 2.1 months

• Number of Participants With Clinically Significant Changes in Vital Signs

  Up to approximately 2.1 months

• Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings

  Up to approximately 2.1 months

Study Arms (1)

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.

Drug: ASN51

Interventions

ASN51 DRUG

Oral

ASN51

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Asceneuron S.A.: lead
• Hammersmith Medicines Research Invicro: collaborator

Study Sites (1)

Hammersmith

London, United Kingdom

Location

Results Point of Contact

• Title: Asceneuron Clinical Research
• Organization: Asceneuron SA

clinicaltrials.gov@asceneuron.com

+ 41 21 353 8245

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: August 9, 2021
• Primary Completion: October 12, 2021
• Study Completion: October 12, 2021
• Last Updated: May 8, 2025
• Results First Posted: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)