New drug AG-181 tested in healthy people for first time
NCT ID NCT06286033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tested the safety and tolerability of a new drug called AG-181 in 88 healthy volunteers. Researchers gave single or multiple doses to see how the body processes the drug and whether it causes any side effects. The study also looked at how food affects drug levels. Since this is a Phase 1 trial in healthy people, it does not test whether the drug works for any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AG-181
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
88 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
-
Oct 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing to participate in the study, give written informed consent, and comply with the study restrictions. * Body mass index in the range of 18.0 to 30.0 kilograms per square meter (kg/m\^2). * Weight ≥ 50 kilograms (kg) at screening. * Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis. * Ability and willingness to refrain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (e.g., coffee, tea, cola, chocolate, energy drinks) from 72 hours (3 days) before administration of the first dose of study drug through follow-up. * All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator. * For women of child bearing potential (WOCBP)\*, have a negative serum pregnancy test at Screening and during admission to the clinic. a. \*WOCBP are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal. WOCBP must use an acceptable method of contraception from Screening and until 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of AG-181. WOCBP using hormonal contraception as a highly effective form of contraception must also use an acceptable barrier method. * Male participants with female partners of childbearing potential must use a condom during treatment and for 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of AG-181. * Male participants must agree not to donate sperm during the study and for 14 days or 5 half-lives of AG-181, whichever is longer, after the last dose of study drug. * Postmenopausal women are women who have not menstruated at all for at least the 12 months before providing informed consent and who have an elevated follicle-stimulating hormone (FSH) level indicative of menopause during screening. * Participants must have discontinued use of prescription drugs (including topical skin preparations other than nonsteroidal/nonantibiotic nonprescription moisturizers) within 2 weeks or 5 half-lives (whichever is longer) of the first dose of study drug, and over-the-counter (OTC) medication (excluding routine vitamins) within 7 days of the first dose of study drug, unless agreed as not clinically relevant by the Investigator and Medical Monitor (or designee). Exclusion Criteria: * Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug. * Males with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 14 days or 5 half-lives of AG-181, whichever is longer, after last dose of study drug. * Prior exposure to AG-181. * Use of any investigational drug or device within 30 days before administration of the first dose of study drug. * Any disease which, in the opinion of the Investigator, poses an unacceptable risk to the participants. * Clinically significant history of, including treatment within an Emergency Department for, any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). * Creatinine clearance \<90 milliliters per minute (mL/min) (by Cockcroft-Gault formula) at screening. * Aspartate aminotransferase \>upper limit of normal (ULN) or alanine aminotransferase \>ULN at screening. * Use of tobacco or nicotine products in the 48 hours (2 days) prior to administration of the first dose of study drug. * Strenuous activity, sunbathing, and contact sports within 48 hours (2 days) prior to administration of the first dose of study drug. * History of donation of more than 450 milliliters (mL) of blood within 60 days prior to administration of the first dose of study drug. * Plasma or platelet donation within 7 days prior to administration of the first dose of study drug. * History within the 12 months before Screening of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink=12 ounce (oz) beer, 5 oz wine, and 1.5 oz spirits). Alcohol consumption will be prohibited 72 hours prior to administration of the first dose of study drug and until discharge. * Positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies at screening. * Consumption of any nutrients known to modulate cytochrome P450 (CYP450) enzymes activity (e.g., grapefruit or grapefruit juice, pomelo juice, star fruit, or Seville \[blood\] orange products) within 14 days prior to administration of the first dose of study drug. * Positive alcohol or drug screen (cannabinoids, amphetamines, methamphetamines, 3,4-methylenedioxy-N-methylamphetamine \[ecstasy\], opiates, methadone, oxycodone, phencyclidine, cocaine, cotinine, benzodiazepines, and barbiturates) at screening or admission to the clinical facility. * Prolonged heart rate-corrected QT interval (QTc) \[heart rate-corrected QT interval by Fridericia's formula (QTcF) \>450 milliseconds (msec)\] during screening and prior to first dose of study drug. * History of long-QT syndrome, torsade de pointes, or any risk factors for torsades de pointes in the opinion of the investigator. * A history in any family member of any of the following: sudden cardiac death, unexplained death, long-QT syndrome, or death from a primary dysrhythmia potentially associated with QT prolongation.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
ICON 1255 East 3900 South
Salt Lake City, Utah, 84124, United States
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