NCT02616445 is a Phase 1 clinical trial of UE2343 in Healthy Volunteers, sponsored by Actinogen Medical.

Who is sponsoring NCT02616445?

NCT02616445 is sponsored by Actinogen Medical.

What drugs are being tested in NCT02616445?

Interventions in NCT02616445: UE2343, Placebo, Placebo, UE2343, UE2343.

What condition does NCT02616445 study?

NCT02616445 studies Healthy Volunteers.

Is NCT02616445 still recruiting?

NCT02616445 is currently completed. Last updated 20 January 2025.

Last reviewed 2025-01-20 · How we verify

NCT02616445

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase I Double-Blind, Randomised, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of UE2343 in Healthy Subjects

Completed Phase 1 Last updated 20 January 2025

What this trial tests

Phase 1 trial testing UE2343 in Healthy Volunteers in 40 participants. Completed in 1 September 2015.

Timeline

1 February 2015

Primary endpoint
1 August 2015

1 September 2015

Quick facts

Lead sponsor	Actinogen Medical
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	40
Start date	1 February 2015
Primary completion	1 August 2015
Estimated completion	1 September 2015
Sites	1 location across Australia

Drugs / interventions tested

UE2343 — full drug profile →
Placebo
Placebo
UE2343 — full drug profile →
UE2343 — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Actinogen Medical — full company profile →

Who can join

Adults 18 to 65, any sex, with Healthy Volunteers. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Assess Safety and Tolerability of UE2343 over 17 days including AEs, 12-lead ECGs, vital signs, Nerve conduction velocity, Labs.
Time frame: Up to Day 17
Assess the Pharmacokinetic (PK) Plasma Parameter Maximum Plasma Concentration (Cmax) of UE2343 after a single dose
Time frame: Day 1 and Day 8
Assess the Pharmacokinetic (PK) Plasma Parameter Time to Cmax (Tmax) of UE2343 after a single dose
Time frame: Day 1 and Day 8
Assess the Pharmacokinetic (PK) Plasma Parameter Area Under the Curve (AUC) of UE2343 after a single dose
Time frame: Day 1 and Day 8
Assess the Pharmacokinetic (PK) Plasma Parameter Terminal Elimination Half Life (t½) of UE2343 after a single dose
Time frame: Day 1 and Day 8
Assess PK Parameter Maximum Plasma Concentration (Cmax) of UE2343 in CSF
Time frame: Day 4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Actinogen Medical trials

Trials by the same sponsor.

NCT05657691 — Xanamem® in Adults With Major Depressive Disorder and Impaired Cognition (XanaCIDD) · Phase 2 · completed
NCT04983368 — A Double-Blind, Placebo-Controlled, Dose Ranging Study of Xanamem® in Healthy Elderly Volunteers · Phase 1, PHASE2 · completed
NCT03830762 — Xanamem™ in Healthy Elderly Subjects · Phase 1 · completed
NCT02727699 — A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (X · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02616445 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Actinogen Medical
Last refreshed: 20 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02616445.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing