RecruitingPhase 1NCT07221240

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects


Sponsor

PRG Science & Technology Co., Ltd.

Enrollment

48 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult subjects through a randomized, double-blind, placebo-controlled Phase 1 study consisting of two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The food effect will be assessed in one cohort in Part1. Approximately 48 healthy, adult subjects are planned to be enrolled in total. Subjects will participate in only one part and one cohort.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing whether a new experimental drug called amisodin is safe and well-tolerated in healthy adults. Even though it's titled around ALS (amyotrophic lateral sclerosis, a progressive neurological disease), this phase is enrolling healthy volunteers to understand how the drug behaves in the body before testing it in patients. **You may be eligible if...** - You are a healthy adult between 18 and 55 years old - If you are female, you must be past menopause or have had a sterilization procedure (the study excludes women of childbearing potential) - You are not taking any regular medications - Your overall health is good based on screening tests **You may NOT be eligible if...** - You are a woman of childbearing potential (able to become pregnant) - You have any significant medical conditions, abnormal lab values, or history of serious illness - You smoke heavily or use drugs - You have participated in another drug trial recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAmisodin

Administered as specified in the treatment arm.

OTHERPlacebo

Administered as specified in the Placebo arm.


Locations(1)

Pharmaron, Inc.

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07221240


Related Trials