Actively Recruiting
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis
Led by PRG Science & Technology Co., Ltd. · Updated on 2026-03-05
48
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years, male or female of non-childbearing potential
- Females of non-childbearing potential defined by sterilization procedures or postmenopausal status with consistent hormone levels
- Male subjects must agree to contraception and avoid sperm donation for 90 days after last dose
- Continuous non-smokers who have not used nicotine products for at least 3 months
- Body mass index between 18.0 and less than 32.0 kg/m2
- Medically healthy with no significant medical history, physical exam, lab profile, or vital signs abnormalities
- Blood pressure between 90/50 mmHg and 140/90 mmHg
- Normal liver function tests
- Estimated glomerular filtration rate of 90 mL/min/1.73 m2 or higher
- Normal ECG findings including normal sinus rhythm, QTcF interval limits, QRS interval less than 110 msec, and PR interval 210 msec or less
- Ability to understand study procedures and comply with protocol
You will not qualify if you...
- Mentally or legally incapacitated or significant emotional problems
- History or presence of clinically significant medical or psychiatric conditions
- History of any illness that might affect study results or increase risk
- History or presence of alcohol or drug abuse within past 2 years
- Allergy or hypersensitivity to study drug, excipients, antihistamines, or medical adhesives
- Female subjects of childbearing potential, pregnant, or lactating
- Positive pregnancy test at screening or check-in
- Positive drug or alcohol test at screening or check-in
- Positive tests for HIV, hepatitis B, or hepatitis C at screening
- Use of any drugs, including prescription, non-prescription, herbal, or vitamin supplements within 14 days before dosing
- Use of drugs inducing cytochrome P450s or P-glycoprotein within 28 days before dosing
- Use of drugs prolonging QT/QTc interval within 14 days before dosing
- On incompatible diet within 30 days before dosing
- Blood donation or significant blood loss within 56 days before dosing
- Plasma donation within 7 days before dosing
- Participation in another clinical study within 90 days before dosing
- Any other reason judged by investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pharmaron, Inc.
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
C
Claudia Jang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here