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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GT-02287 in Parkinson's Disease

NCT06732180 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-06

No results posted yet for this study

Summary

The main goal of this clinical trial is to learn about the safety and tolerability of GT-02287. The questions it aims to answer are:

* What medical problems do participants have when taking GT-02287?
* How is GT-02287 absorbed, distributed, and removed from the body of participants over time (pharmacokinetics)?
* Are there any biological effects of GT-02287 in blood and in cerebrospinal fluid that could be beneficial for people with Parkinson's disease?

Participants will:

* visit the clinic to assess if they qualify for the study (30-day Screening Period)
* if eligible, receive GT-02287 once a day every day for 90 days (90-day Open Label Treatment period)
* visit the clinic the first day of treatment, after the first 2 weeks of treatment, and every month during the 90-day Treatment Period.
* visit the clinic to assess how they are doing 14 days after the end of GT-02287 treatment (14-day Follow-Up Period).

Conditions

  • Parkinson Disease

Interventions

DRUG

GT-02287

Dose of 13.5 mg/kg/day (plus/minus 2 mg/kg/day based on body weight) to be administered orally once a day for 90 days. Dosage form: powder in sachet (200 mg of GT-02287 per sachet) for reconstitution with a suspending agent

Sponsors & Collaborators

  • Gain Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Gain Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2025-11-30
Completion
2025-11-30

Countries

  • Australia

Study Locations

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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 NCT06732180 on ClinicalTrials.gov