NCT05725005

PET Study of Repeated ASN51 in Healthy Volunteers

A Phase 1, Open-label, Positron Emission Tomography Study in Healthy Subjects to Determine the Relationship Between Plasma Concentration and Target Occupancy of ASN51 Following Repeated Oral Doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Asceneuron S.A. · Industry
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, open-label, dose escalation, positron emission tomography (PET) study to investigate the brain occupancy of O-GlcNAcase, and the pharmacodynamics (PD) response in peripheral blood mononuclear cells (PBMCs), after repeated doses of ASN51 in healthy participants.

Detailed description

The clinical data from the first-in-human single- and multiple-ascending dose study of ASN51 (ASN51-101), and the adaptive-design PET study of O-GlcNAcase brain ASN51 occupancy after single oral doses (ASN51-102), showed acceptable safety, tolerability and pharmacokinetics (PK). However, to date, no assessment of receptor occupancy (RO) after multiple doses of ASN51 and at plasma concentrations below the EC50 have been done. Hence, the purpose of this study is to assess brain O-GlcNAcase RO using PET following repeated doses of ASN51. The study will also characterise the PBMC response (including the effect of food), and further assess the safety, tolerability, PK, and PK/RO relationship, after repeated ASN51 doses. The results of this study will be used to select doses for subsequent studies in participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ASN51	Oral capsule

Timeline

• Start date: 2023-01-26
• Primary completion: 2023-04-04
• Completion: 2023-06-08
• First posted: 2023-02-13
• Last updated: 2025-05-08
• Results posted: 2025-05-08

Locations

1 site across 1 country: United Kingdom