ALG-097558 for Coronavirus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the experimental drug ALG-097558 interacts with other medications and its absorption in the body. The researchers aim to determine if ALG-097558 affects or is affected by other drugs and how food might alter its absorption. The study seeks healthy volunteers who are non-smokers and free from significant health issues. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
Yes, participants must stop taking any medications, vitamins, and herbal supplements at least one week before the study, except for contraceptives and limited doses of ibuprofen or acetaminophen.
Is there any evidence suggesting that ALG-097558 is likely to be safe for humans?
Research has shown that ALG-097558 has been tested in studies with healthy volunteers. Results suggest that this drug is generally well-tolerated over a 7-day treatment period. No reports have indicated the need for ritonavir, a medication often used to enhance antiviral treatments, which suggests a good safety profile. While specific side effects were not mentioned, the absence of additional medication to manage the drug's effects is a positive sign. As an early-phase study, it is designed to closely monitor safety and any side effects, providing extra reassurance. Each person's experience can differ, so discussing participation with a healthcare provider is advisable.12345
Why are researchers excited about this trial's treatment?
Researchers are excited about ALG-097558 because it offers a potential new way to tackle coronavirus infections. While most treatments focus on reducing symptoms or acting as antivirals like remdesivir, ALG-097558 introduces a novel mechanism that might enhance its effectiveness. This treatment is administered in a spray-dried dispersion tablet form, which could improve absorption and efficacy compared to conventional tablets. Such innovative drug delivery methods might lead to faster and more reliable results, making ALG-097558 a promising candidate in the fight against coronavirus.
What evidence suggests that ALG-097558 could be an effective treatment for coronavirus?
Research has shown that ALG-097558, which participants in this trial will receive in various formulations and dosages, could be a promising treatment for coronavirus. It demonstrated high effectiveness in lab tests against different coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. ALG-097558 blocks a key enzyme the virus needs to multiply, making it effective against various coronavirus variants. In studies, ALG-097558 proved more effective against certain coronaviruses than some other treatments under investigation. These early results suggest that ALG-097558 could be a strong option for fighting coronavirus infections.34567
Are You a Good Fit for This Trial?
Healthy adults aged 18-65, nonsmokers for at least 3 months, with a BMI of 18.0 to 32.0 kg/m^2 can join this trial. Women must be postmenopausal, permanently sterile or using effective birth control; men must use condoms during the study and not donate sperm for 90 days after.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part A - Drug-Drug Interaction Evaluation
Evaluate the effect of itraconazole on the pharmacokinetics of ALG-097558 and its metabolite
Part B - Drug-Drug Interaction Evaluation
Evaluate the effect of ALG-097558 on the pharmacokinetics of dabigatran
Part C - Bioavailability and Food Effect Study
Study the bioavailability of ALG-097558 and the effect of food on its pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ALG-097558
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor