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Phase I MAD, Fed-Fasted, CSF Study of UE2343 in Healthy Subjects

NCT02616445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-01-22

No results posted yet for this study

Summary

The purpose of this study is to determine whether the drug UE2343, a potential treatment for Alzheimer's Disease (AD), is effective by assessing safety, tolerability, pharmacokinetics and pharmacodynamics in a Multiple Ascending Dose Study. Protocol amendments to the study will examine any food effect and determine if the drug penetrates the Blood-Brain Barrier.

Conditions

  • Healthy Volunteers

Interventions

DRUG

UE2343

* UE2343 * 10mg, 20, 35mg * twice daily for 9 days

DRUG

Placebo

* 10mg, 20, 35mg * twice daily for 9 days

DRUG

Placebo

* Cross-over study * single dose administered twice (on day 1 and day 8) * study duration 17 days

DRUG

UE2343

* Cross-over study * UE2343 * single dose administered twice (on day 1 and day 8) * study duration 17 days

DRUG

UE2343

* UE2343 * twice daily for 3 days * single dose on day 4

Sponsors & Collaborators

  • Novotech (Australia) Pty Limited

    collaborator INDUSTRY

  • Linear Clinical Research

    collaborator INDUSTRY

  • Actinogen Medical

    lead INDUSTRY

Principal Investigators

  • Vincent Ruffles · Actinogen Medical

  • Janakan Krishnarajah · Linear Clinical Research Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-08-31
Completion
2015-09-30

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 NCT02616445 on ClinicalTrials.gov