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Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Oral ASN51 in Healthy Subjects and Subjects With Alzheimer's Disease

NCT04759365 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-01-17

No results posted yet for this study

Summary

ASN51-101 is a randomized, double-blind, placebo-controlled, phase 1 first in human (FIH) safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) study of oral ASN51 in healthy young adult and elderly subjects and elderly subjects with AD. The study is comprised of three parts (Part 1, Part 2, and Part 3).

Conditions

  • Alzheimer Disease

Interventions

DRUG

ASN51

ASN51 formulation for oral capsule

DRUG

Placebo

Placebo formulation for oral capsule

Sponsors & Collaborators

  • Asceneuron S.A.

    collaborator INDUSTRY

  • Neuroscience Trials Australia

    collaborator OTHER

  • Asceneuron Pty Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759365 on ClinicalTrials.gov