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Study of Amisodin in Healthy Adults

This study is testing a drug called Amisodin in healthy adults to understand its safety, how well the body tolerates it, and how it moves through the body (pharmacokinetics). It is a Phase 1 study, which means it's an early-stage study in people. Researchers want to see if Amisodin causes any side effects and how severe they are. About 48 healthy adults, aged 18 to 55, will participate. The study is double-blind, meaning neither you nor the study team will know if you are receiving Amisodin or a placebo (an inactive substance that looks like the drug). The study is currently recruiting participants.

Study design
This is a randomized, double-blind, placebo-controlled Phase 1 study with approximately 48 healthy adult participants. Participants will receive either Amisodin or a placebo.
What's involved
Participants will receive a single dose of Amisodin or placebo, or daily doses for 7 days. Safety assessments, including blood tests and physical exams, will be conducted.
Compensation
Not stated in the trial record.
Follow-up
You will be followed until 7 days after your last dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07221240

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
PRG Science & Technology Co., Ltd.
~48 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:AmisodinPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number and severity of TEAEs following a single oral dose of Amisodin and placebo.
Measured over From signing of the informed consent form until the follow-up visit (7 days [± 1 day] after dosing).

Conditions

Amyotrophic Lateral Sclerosis

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Amyotrophic Lateral Sclerosis

NCT07221240

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Pharmaron, Inc.

    Baltimore, Marylandstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Claudia Jang
[email protected]
+82 051-583-8703
Email the study team

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Eligibility criteria

Inclusion

1\. Healthy, adult, male or female (of non-childbearing potential only)\*, 18 55 years of age, inclusive, at the screening visit.
Females of non-childbearing potential are defined as follows:
Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
Bilateral oophorectomy or
Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and have follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status. 2. Male subjects must follow protocol specified contraception guidance as described in Section 7.4.5 Contraception Requirements and agree to refrain from sperm donation until 90 days after the last dosing. 3. Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
Seated blood pressure is ≥ 90/50 mmHg and ≤ 140/90 mmHg
Liver function tests at or below limit or normal range
Estimated glomerular filtration rate (estimated by Modification of Diet in Renal Disease Study equation \[MDRD\] method) ≥ 90 mL/min/1.73 m² 6. No ECG findings of clinical significance as judged by the PI or qualified designee at the screening visit and at first check in, including each criterion as listed below:
Normal sinus rhythm (heart rate between 40 and 100 bpm, inclusive)
QTcF interval ≤ 450 msec (males) or ≤ 460 msec (females)
QRS interval \< 110 msec; if \> 110 msec, result will be confirmed by a manual over read
PR interval ≤ 210 msec 7. Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.

Exclusion

1\. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.

What this trial measures

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

    To evaluate the safety and tolerability of a single ascending dose of Amisodin in healthy adult subjects.