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ANZCTR12623000860662Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of GT-02287 in Healthy Participants

A First-in-Human, Randomized, Double-blind, Dose Escalation, Single and Multiple Ascending Dose (SAD/MAD) Study to Assess the Safety, Tolerability, Pharmacokinetics, and Food Effect of GT-02287 in Healthy Participants
Gain Therapeutics, Australia Pty LtdPhase 1Australian New Zealand Clinical Trials Registrydrug
VerifiedAustralian New Zealand Clinical Trials Registry
Study focus
Disease/Condition
Parkinson's Disease
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Gain Therapeutics, Australia Pty Ltd
Funder
Gain Therapeutics, Inc.
Location
Australia
Timeline & enrollment
Phase
Phase 1
Start date
Sep 28, 2023
End date
May 03, 2024
Primary outcome

To evaluate the safety and tolerability of single and multiple ascending oral doses of GT-02287 in healthy adult participants. Safety will be assessed by evaluation of the Incidence, nature, and severity of all adverse events (AEs) from Screening to Follow-up visit, including time of onset/offset from administration of GT 02287.;; To evaluate the safety and tolerability of single and multiple ascending oral doses of GT-02287 in healthy adult participants. Safety will be assessed by evaluation of the Incidence of clinically significant findings for: - Clinical laboratory evaluations (hematology, coagulation, biochemistry, and urinalysis) - Physical and neurological examinations - Vital signs measurements (tympanic temperature, resting pulse, and resting pressure [BP]) - 12-lead electrocardiograms (ECGs);; To evaluate the safety and tolerability of single and multiple ascending oral doses of GT-02287 in healthy adult participants. Safety will be assessed by evaluation of Questionnaires: Bond and Lader Visual Analogue Scale (BL-VAS), Profile of Mood States Short Form (POMS-SF) and Columbia Suicide Severity Rating Scale (C SSRS).

Summary

This phase 1 study is a randomized, placebo-controlled, double-blind, trial of an oral drug called GT 02287 vs. placebo in healthy volunteers. The study will assess the safety, tolerability, Pharmacokinetics, and Food Effect in single and multiple ascending dose cohorts.

ICD-10 classifications
Parkinson diseaseParkinsonism in diseases classified elsewhereDementia in Parkinson diseaseSecondary parkinsonismPostencephalitic parkinsonism
Data source
Registry
Australian New Zealand Clinical Trials Registry
Trial ID
ANZCTR12623000860662
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for ANZCTR12623000860662 through Pure Global AI's free database. This Phase 1 trial is sponsored by Gain Therapeutics, Australia Pty Ltd and is currently Recruiting. The study focuses on Parkinson's Disease.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Australian New Zealand Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.