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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
PRG Science & Technology Co., Ltd.
Study ID
NCT07221240
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Amisodin — DRUG
    Administered as specified in the treatment arm.
  • Placebo — OTHER
    Administered as specified in the Placebo arm.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Mar 2026
Primary completion
May 27, 2026
Completion
Jul 3, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Drug: Amisodin
    Subjects who have successfully completed the screening phase will enter the treatment phase of the study and be randomized to a treatment arm. Subjects randomized to the Amisodin arm will receive orally administered Amisodin either as a single ascending dose (SAD) or multiple ascending doses (MAD) under fasting conditions, with one cohort in the SAD part crossing over to receive the same dose under fed conditions to assess the effect of food.
  • Placebo Comparator: Drug: Placebo
    Subjects who have successfully completed the screening phase will enter the treatment phase of the study and be randomized to a Placebo arm. Subjects randomized to the Placebo arm will receive orally administered Placebo either as a single ascending dose (SAD) or multiple ascending doses (MAD) under fasting conditions.

Primary Outcome Measure

Number and severity of TEAEs following a single oral dose of Amisodin and placebo. [ Time Frame: From signing of the informed consent form until the follow-up visit (7 days [± 1 day] after dosing). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pharmaron, Inc.BaltimoreMaryland21201
James Phillips
[email protected]
+82 051-583-8703

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By research site
Pharmaron, Inc.· Baltimore, MD

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