Amisodin for ALS
(ALS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerance of a new oral drug, Amisodin. It aims to understand how the body processes this drug, potentially aiding future treatments for conditions like ALS, which affects nerve cells in the brain and spinal cord. Participants will receive either Amisodin or a placebo (a harmless pill with no active drug) in varying doses to observe its effects in the body. Ideal candidates for this trial are healthy adults who do not smoke and have no significant medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, assisting researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription or non-prescription medications, herbal remedies, or vitamin supplements 14 days before the trial starts. Additionally, you must avoid certain drugs that affect liver enzymes for 28 days before the trial.
Is there any evidence suggesting that Amisodin is likely to be safe for humans?
Previous studies have examined the safety and pharmacokinetics of Amisodin, a new drug for ALS, a disease that weakens muscles. Although specific safety data is not yet available, this trial is in its early stages. The main goal is to determine if Amisodin is safe and well-tolerated in healthy adults. Early-stage trials often mark the first time a drug is tested in humans, making safety a key focus. If Amisodin proves safe in this group, it can proceed to further testing.12345
Why do researchers think this study treatment might be promising for ALS?
Unlike the standard treatments for ALS, which often focus on managing symptoms, Amisodin offers a potentially new approach by targeting the disease at its core. Researchers are excited about Amisodin because it is designed to be administered orally, making it more convenient than many existing therapies that require injections or infusions. Additionally, Amisodin is being tested in both single and multiple ascending doses, which could provide flexibility in treatment options and dosing regimens. This novel delivery and dosing strategy, combined with its unique mechanism of action, sets Amisodin apart and fuels hope for improved outcomes in ALS care.
What evidence suggests that Amisodin might be an effective treatment for ALS?
Research has shown that Amisodin might help people with ALS, a disease affecting nerve cells in the brain and spinal cord. In studies with mice having a condition similar to ALS, Amisodin improved their muscle strength and mobility. It also preserved the health of nerve cells needed for movement. This trial will compare Amisodin with a placebo to evaluate its effectiveness in humans. Participants will be randomly assigned to receive either Amisodin or a placebo. However, further research is needed to confirm its effectiveness in humans.45678
Are You a Good Fit for This Trial?
This trial is for healthy adults who have ALS. Participants will be given either a new medication called Amisodin or a placebo to test its safety and how the body processes it. They must only take part in one part of the study, either with single doses or multiple doses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single oral dose of Amisodin or placebo under fasting conditions, with one cohort crossing over to receive the same treatment under fed conditions to assess the effect of food.
Multiple Ascending Dose (MAD)
Participants receive Amisodin or placebo once daily for 7 days under fasting conditions.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Amisodin
- Placebo
Trial Overview
The study tests Amisodin's safety and how it's absorbed, broken down, and removed from the body in ALS patients. It's randomized (participants are put into groups by chance) and double-blind (neither researchers nor participants know who gets what treatment).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
PRG Science & Technology Co., Ltd.
Lead Sponsor
Citations
Study to Evaluate Safety, Tolerability, and ...
During this trial, a total of 32 subjects will be randomized in a 3:1 ratio (out of 8 subjects, 6 on Amisodin, 2 on placebo in each dose group).
Amisodin for ALS (ALS Trial)
Trial Overview The study tests Amisodin's safety and how it's absorbed, broken down, and removed from the body in ALS patients. It's randomized (participants ...
Amisodin - Drug Targets, Indications, Patents
Administration of PRG-A01 into the ALS model mouse resulted in significant improvement of muscle strength, motor neuron viability and mobility with extended ...
New phase 1 in healthy volunteers for an oral drug ...
"ASC30 oral tablet has shown promising efficacy and safety data, which once again demonstrated our strong R&D capabilities to develop more ...
Amisodin in Amyotrophic Lateral Sclerosis - ICH GCP
During this trial, a total of 32 subjects will be randomized in a 3:1 ratio (out of 8 subjects, 6 on Amisodin, 2 on placebo in each dose group).
NCT07221240 | Study to Evaluate Safety, Tolerability, and ...
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Amisodin in Healthy Adult Subjects With Amyotrophic Lateral Sclerosis (ALS) (ALS).
KDDF: advancing neurodegenerative disorder drugs
PRG S&Tech Inc., a biopharma company with a focus on rare genetic disorders, is developing Amisodin, a first-in-class, small-molecule oral drug for ALS.
Clinical Trial: Study to Evaluate Safety, Tolerability, and ...
Brief Summary: Researchers will evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered Amisodin in healthy adult ...
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