AG-236 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new treatment called AG-236 in healthy individuals. Participants will receive a single dose of either AG-236 or a placebo (a substance with no therapeutic effect) to observe their body's reactions. This study targets individuals who are generally healthy and meet specific health criteria, such as having a stable body weight and no significant medical history. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or nonprescription medications, including vitamins and herbal supplements, at least 28 days before the study starts, unless the investigator decides otherwise.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that AG-236 remains in the early stages of testing its safety in humans. As this study is in the first phase of trials, the main goal is to determine the treatment's safety and how well people tolerate it. Researchers observe how the body reacts to a single dose of AG-236 and monitor for any side effects.
This means the treatment is being tested in people for the first time. At this stage, side effects and reactions are closely monitored but not yet well-known. So far, no detailed reports from other studies on AG-236 provide specific safety data. As a phase 1 trial, any new information about safety and side effects will enhance understanding of AG-236's impact on humans. Participants should know this is a crucial step in determining the treatment's safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AG-236 because it offers a potentially new way to approach treatment through its unique mechanism of action. While most treatments for various conditions work through familiar pathways, AG-236 targets specific biological processes that may lead to more effective outcomes with fewer side effects. Additionally, the study explores different dosage levels, which could provide insights into optimizing efficacy and safety. This innovative approach has the potential to enhance treatment precision and improve patient experiences compared to traditional options.
What evidence suggests that AG-236 could be effective?
AG-236 is a new drug undergoing testing to determine its safety and tolerability in healthy individuals. Participants in this trial will receive a single dose of AG-236 at one of three different dose levels or a placebo. Specific information on its effectiveness for treating certain conditions is not yet available. The drug is administered as an injection just under the skin, allowing for slow and steady absorption. The current focus is on understanding reactions to a single dose, which will aid in predicting its potential use in real treatments. As research progresses, clearer insights into its effectiveness for specific conditions will emerge.12367
Are You a Good Fit for This Trial?
This trial is for healthy individuals who want to help test a new medication. There are specific requirements and exclusions that aren't listed here, but generally, participants should be in good health without any major medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of AG-236 or placebo under fasted conditions
Follow-up
Participants are monitored for safety and pharmacokinetics after receiving the dose
What Are the Treatments Tested in This Trial?
Interventions
- AG-236
Find a Clinic Near You
Who Is Running the Clinical Trial?
Agios Pharmaceuticals, Inc.
Lead Sponsor