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

NCT04759365 | Terminated Phase 1

• 1 other identifier: ASN51-101
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 38 days

Secondary Outcomes (20)

• PK parameter: The area under the concentration-time curve from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) in plasma

  Up to 10 days

• PK parameter: The area under the concentration-time curve from zero to infinity (AUC0-inf) in plasma

  Up to 10 days

• PK parameter: The maximum concentration (Cmax) at steady state in plasma

  Up to 10 days

• PK parameter: The time to reach maximum concentration (tmax) in plasma

  Up to 10 days

• PK parameter: The terminal elimination rate constant (λZ) with the respective half-life (t½) in plasma

  Up to 10 days

Study Arms (2)

ASN51

EXPERIMENTAL

ASN51 will be administered as an oral capsule

Drug: ASN51

Placebo

PLACEBO COMPARATOR

Placebo will be administered as an oral capsule

Drug: Placebo

Interventions

ASN51 DRUG

ASN51 formulation for oral capsule

ASN51

Placebo DRUG

Placebo formulation for oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Men and women aged 18-55 years, inclusive, at Screening (Part 1) or 55-80 years, inclusive, at Screening (Part 2)
• Subject must understand the nature of the study and provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures.
• Able to complete all study related testing and evaluations
• Women (Part 1 only) and men of child-bearing potential with partners of child-bearing potential must agree to use highly effective contraception. Contraception should consist of: (1) a condom for the male participant or partner of a female participant, combined with (2) a highly effective method of contraception (e.g., a hormonal method associated with suppression of ovulation, an intrauterine device \[IUD\]) for the female participant or partner of a male participant. Abstinence from heterosexual intercourse should only be used in place of contraception when this is consistent with the usual and preferred lifestyle of the participant. For male subjects, contraception should continue for 90 days after the last dose of investigational medicinal product (IMP, one spermatic cycle). Male subjects should agree to refrain from sperm donation throughout this same period.
• Women of non-childbearing potential must be post-menopausal (the last menstrual period was at least 12 months ago, and follicle-stimulating hormone \[FSH\] at Screening confirms post-menopausal status), or have no uterus, ovaries, or fallopian tubes (or have their fallopian tubes tied). All women must have a negative pregnancy test result before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
• Body weight \> 50.0 kg for men and \> 50 kg for women and Body Mass Index (BMI) within the range 18.5-30.0 kg/m2, inclusive.
• Subject 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.
• Subjects is fluent in the local language.
• Subject agrees 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 been completed, this does not include information about participating in a clinical study in general.
• \[Part 2 only\] Subject is able to undergo Lumbar Puncture (LP)
• A positive urine drug screen/alcohol breath test at Screening or Day -1.
• Any history of intellectual disability or psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, except a history of mild depression/anxiety that has been resolved for at least the past 12 months.
• A positive Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) antibody test 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 administration.
• Frequent use of 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 1 week before study drug administration. Frequent use is defined as more than 10 cigarettes or equivalent per week. Use of any tobacco or nicotine-containing product is prohibited from 1 week prior to study drug administration throughout the study (final visit).

Sponsors & Collaborators

• Asceneuron Pty Ltd.: lead
• Asceneuron S.A.: collaborator
• Neuroscience Trials Australia: collaborator

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: June 2, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)